Contraception
Conditions
Brief summary
This is a feasibility, multi-center, open-label, non-significant risk device study for a non-hormonal contraceptive ring.
Detailed description
The purpose of this clinical trial is to assess the ability of Ovaprene™ to prevent sperm from penetrating midcycle cervical mucus. In addition, safety, release of ingredients, acceptability and fit will be assessed.
Interventions
DEVICEOvaprene
non-hormonal contraceptive ring
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Daré Bioscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women aged 18-50 years, inclusive 2. General good health, by volunteer history and per investigator judgment 3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report 4. History of Pap tests and follow-up consistent with standard medical practice or willing to undergo a Pap test at Visit 1. 5. Protected from pregnancy by female tubal sterilization 6. Willing to abstain from or engage in intercourse with and without condoms and to abstain from other vaginal activity as required in the protocol 7. In a mutually monogamous relationship for at least the last four months with a male partner who: 1. Is at least 18 years old; 2. Has no known risk for Sexually Transmitted Infections (STIs); 3. Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements; and 4. Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol 8. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy colposcopy and genital tract sample collection 9. Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol
Exclusion criteria
1. History of hysterectomy 2. Vasectomy in male partner 3. Sterility or known history of sperm dysfunction in male partner 4. Within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome. 5. Current use of any hormonal contraceptive or a copper IUD (intra-uterine device), or use of Depo-Provera within the last 120 days 6. Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study 7. Significant gynecological abnormalities (including abnormal vaginal bleeding or excessive vaginal discharge) 8. Either device does not appropriately fit volunteer, as determined by clinician 9. Inability of the volunteer to insert, position, and/or remove either device, even with assistance 10. History of sensitivity/allergy to nonoxynol-9 or to silicone or any other component of Ovaprene™ or Caya, for either the volunteer or her male partner 11. In the last four months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women or male partners with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility 12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or HIV 13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection 14. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.) 15. Known current drug or alcohol abuse which could impact study compliance. (This is defined as any illicit drug use or more than 15 alcoholic drinks per week) 16. Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study 17. History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days 18. Abnormal finding on laboratory or physical examination or a social or medical condition in either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data 19. Nugent score greater than or equal to 7 20. Systemic use in the last two weeks or anticipated use during the study of antibiotics (other than those used to treat urinary tract infection (UTI), vaginal candidiasis, or bacterial vaginosis (BV) diagnosed at Visit 1, or to treat UTI or vaginal candidiasis after Visit 1) or topical antivirals (e.g., acyclovir or valacyclovir). Note: Participants should avoid non-steroidal anti-inflammatory drugs (NSAIDs) and Tylenol except for occasional use, as in treatment of headaches or dysmenorrhea. 21. Grade 2 or higher abnormality per the March 2017 update of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Disease (NIAID) Table for Grading of the Severity of Adverse Events or clinically significant lab abnormalities as determined by the investigator (see Section 13.5 for link to DAIDS table) 22. Inability to achieve adequate cervical mucus in two attempts at the baseline cycle 23. Inadequate sperm in endocervical aspirate during baseline testing without any device, despite adequate mucus and presence of sperm in vaginal pool
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use. | Baseline to OVP PCTa at 175 Days | All participants had fewer than 5 progressively motile sperm per high power field (PMS/HPF) in all cycles during Ovaprene use. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device. | OVP Cycle A Visit 13 (Day 121) to Visit 14 (Day 122) and OVP Cycle B Visit 18 (Day 156) to Visit 19 (Day 157). | Evaluating the change in CVF pH before and after intercourse when the Ovaprene device was being worn during intercourse. |
| Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) During Use of the Device. | 175 days | Number of participants within the Ovaprene population that experienced a Urogenital treatment emergent adverse event (AE). |
| Number of Participants With Changes in Pelvic Exam Findings From Baseline | 175 days | Pelvic exams were completed at all 21 visits via a vaginal Colposcopy procedure. |
| Changes From Baseline in Nugent Score | 175 days | Nugent scores were calculated prior to the insertion of each Ovaprene device and then after the device was removed at the end of each cycle. Nugent score is a gram stain storage system assessing vaginal bacteria present on a scale of 0-10. Scores ranging from 7-10 are indicative of bacterial vaginosis. |
| Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid. | Pre Baseline (Day 1) to Post Baseline (Day 2); OVP PCTa Pre Intercourse (Visit 13, Day 121) to Post Intercourse (Visit 14, Day 122) and PCTb Pre Intercourse (Visit 18, Day 156) to Post Intercourse (Visit 19, Day 157). | Measuring the E.coli inhibition (%) pre and post intercourse |
| Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | Pre Baseline (Day 1) to Post Baseline (Day 2); OVP PCTa Pre Intercourse (Visit 13, Day 121) to Post Intercourse (Visit 14, Day 122) and PCTb Pre Intercourse (Visit 18, Day 156) to Post Intercourse (Visit 19, Day 157). | Measurement of Interleukin-1 Beta (pg IL-1Beta/ug Protein), Interleukin-8 (pg IL-8/ug Protein), Secretory leukocyte Peptidase Inhibitor (SLPI) |
| Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Absence of the Study Device. | Pre-Intercourse (Baseline Visit 1) and Post-Intercourse (Baseline Visit 2) (24hrs) | Evaluating the change in CVF pH before and after sex with no device present. |
| Number of Devices With Presence of Group A Streptococcus That Have Been Worn for One Cycle. | 35 days (one full cyle) | Vaginal samples and swabs of the used Ovaprene devices were tested for group A Streptococcus. |
| Summary of the Acceptability of the Study Device Among Male and Female Participants. | 175 days | Summary of Open-Ended Acceptability Questionnaire |
| Participants Who Could be Fitted With the Ovaprene Device | Screening or BP3 Visit (2 days) | — |
| Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Visit 3 (BP3, Day 15-20); Visit 7 (OS1, Day 84); Visit 12 (OP1a, Day 112); Visit 13 (OP2a, Day 122-132); Visit 17 (OP1b, Day 140); UNS could occur at any point during the 175 day study duration | Number of participants that required written instructions, those who required written and verbal instructions and those who needed physical assistance. |
| Location of Ovaprene in Relation to Cervix | 175 days | Location was determined digitally and visually by the investigators. |
| Number of Participants With a Study Devices That Has Been Worn for One Cycle With Staphylococcus Aureus Presence on Study Device. | 35 days (one complete cycle) | Vaginal samples and swabs of the used Ovaprene devices were tested for growth of staphylococcus aureus. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Population Healthy, sexually active women who are not at risk for pregnancy due to previous female tubal sterilization will receive both Ovaprene and the Caya diaphragm throughout the course of the trial. The purpose of the Caya PCT cycle is to ensure that in this study population and at these sites, results that are expected to be observed in a PCT cycle with an approved vaginal barrier can be replicated. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | All Enrolled Population |
|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 6.83 |
| BMI | 29.93 kg/m^2 STANDARD_DEVIATION 8.723 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 35 |
| other Total, other adverse events | 21 / 33 | 0 / 35 |
| serious Total, serious adverse events | 0 / 33 | 0 / 35 |
Outcome results
Primary
Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use.
All participants had fewer than 5 progressively motile sperm per high power field (PMS/HPF) in all cycles during Ovaprene use.
Time frame: Baseline to OVP PCTa at 175 Days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovaprene Population | Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use. | Number of participants with an Average of Fewer than 5 PMS/HPF in Cervical Mucus at Baseline | 0 Participants |
| Ovaprene Population | Changes From Baseline in the Post Coital Test Results (PCT) Due to Device Use. | Number of participants with an Average of Fewer than 5 PMS/HPF in Cervical Mucus at OVP3A | 26 Participants |
Other Pre-specified
Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid.
Measuring the E.coli inhibition (%) pre and post intercourse
Time frame: Pre Baseline (Day 1) to Post Baseline (Day 2); OVP PCTa Pre Intercourse (Visit 13, Day 121) to Post Intercourse (Visit 14, Day 122) and PCTb Pre Intercourse (Visit 18, Day 156) to Post Intercourse (Visit 19, Day 157).
Population: The number of participants analyzed is based on the number of viable samples collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ovaprene Population | Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid. | Baseline Pre-Intercourse (Visit 3) | 29.81 % inhibition of vaginal bacterial growth | Standard Deviation 40.16 |
| Ovaprene Population | Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid. | Baseline Post-Intercourse (Visit 4) | -7.42 % inhibition of vaginal bacterial growth | Standard Deviation 37.54 |
| Ovaprene Population | Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid. | OVPa Pre-Intercourse (Visit 13) | 27.23 % inhibition of vaginal bacterial growth | Standard Deviation 47.47 |
| Ovaprene Population | Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid. | OVPa Post-Intercourse (Visit 14) | 15.66 % inhibition of vaginal bacterial growth | Standard Deviation 46.41 |
| Ovaprene Population | Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid. | OVPb Pre-Intercourse (Visit 18) | 28.10 % inhibition of vaginal bacterial growth | Standard Deviation 40.85 |
| Ovaprene Population | Changes From Baseline in Antibacterial (Anti-E. Coli) Activity in Cervicovaginal Fluid. | OVPb Post-Intercourse (Visit 19) | 10.62 % inhibition of vaginal bacterial growth | Standard Deviation 37.7 |
Other Pre-specified
Changes From Baseline in Nugent Score
Nugent scores were calculated prior to the insertion of each Ovaprene device and then after the device was removed at the end of each cycle. Nugent score is a gram stain storage system assessing vaginal bacteria present on a scale of 0-10. Scores ranging from 7-10 are indicative of bacterial vaginosis.
Time frame: 175 days
Population: Baseline was defined as the first visit of the Ovaprene Cycle (OS1 (Visit 7), OP1a (Visit 12), OP1b (Visit 17)) For Nugent Scores.~The OS Cycle (Safety cycle) was the 3rd cycle for each participant approximately Days 84 to 105. OPa was the 4th cycle (approximately Days 112 to 140) and OPb was the 5th cycle (approximately days 140 to 175).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ovaprene Population | Changes From Baseline in Nugent Score | Change from OS1 to OS2 | 0.8 Score (0-10) | Standard Deviation 1.79 |
| Ovaprene Population | Changes From Baseline in Nugent Score | Change from OS1 to OS3 | 1.3 Score (0-10) | Standard Deviation 3.16 |
| Ovaprene Population | Changes From Baseline in Nugent Score | Change from OS1 to OS4 | 1.3 Score (0-10) | Standard Deviation 2.75 |
| Ovaprene Population | Changes From Baseline in Nugent Score | Change from OS1 to OS5 | 0.9 Score (0-10) | Standard Deviation 2.03 |
| Ovaprene Population | Changes From Baseline in Nugent Score | Change from OP1A to OP5A | -0.2 Score (0-10) | Standard Deviation 2.63 |
| Ovaprene Population | Changes From Baseline in Nugent Score | Change from OP1B to OP5B | 1.1 Score (0-10) | Standard Deviation 2.59 |
Other Pre-specified
Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid.
Measurement of Interleukin-1 Beta (pg IL-1Beta/ug Protein), Interleukin-8 (pg IL-8/ug Protein), Secretory leukocyte Peptidase Inhibitor (SLPI)
Time frame: Pre Baseline (Day 1) to Post Baseline (Day 2); OVP PCTa Pre Intercourse (Visit 13, Day 121) to Post Intercourse (Visit 14, Day 122) and PCTb Pre Intercourse (Visit 18, Day 156) to Post Intercourse (Visit 19, Day 157).
Population: The number of participants analyzed corresponds to the number of viable samples received for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ovaprene Population | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | Baseline Pre-Intercourse (Visit 2) | 0.075 pg/ug | Standard Deviation 0.144 |
| Ovaprene Population | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | Baseline Post-Intercourse (Visit 3) | 0.093 pg/ug | Standard Deviation 0.192 |
| Ovaprene Population | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPa Pre-Intercourse (Visit 13) | 0.101 pg/ug | Standard Deviation 0.134 |
| Ovaprene Population | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPa Post-Intercourse (Visit 14) | 0.111 pg/ug | Standard Deviation 0.223 |
| Ovaprene Population | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPb Pre-Intercourse (Visit 18) | 0.119 pg/ug | Standard Deviation 0.264 |
| Ovaprene Population | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPb Post-Intercourse (Visit 19) | 0.141 pg/ug | Standard Deviation 0.342 |
| Ovaprene Population, PCT B | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPb Post-Intercourse (Visit 19) | 0.4291 pg/ug | Standard Deviation 0.3 |
| Ovaprene Population, PCT B | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | Baseline Pre-Intercourse (Visit 2) | 2.6563 pg/ug | Standard Deviation 7.3156 |
| Ovaprene Population, PCT B | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPa Post-Intercourse (Visit 14) | 0.7870 pg/ug | Standard Deviation 0.7914 |
| Ovaprene Population, PCT B | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPb Pre-Intercourse (Visit 18) | 1.5135 pg/ug | Standard Deviation 1.3988 |
| Ovaprene Population, PCT B | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | Baseline Post-Intercourse (Visit 3) | 3.3688 pg/ug | Standard Deviation 7.9979 |
| Ovaprene Population, PCT B | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPa Pre-Intercourse (Visit 13) | 1.2470 pg/ug | Standard Deviation 0.8429 |
| Ovaprene Population, SLPI | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | Baseline Post-Intercourse (Visit 3) | 2175.645 pg/ug | Standard Deviation 1895.113 |
| Ovaprene Population, SLPI | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPa Pre-Intercourse (Visit 13) | 282.344 pg/ug | Standard Deviation 248.081 |
| Ovaprene Population, SLPI | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPb Post-Intercourse (Visit 19) | 700.894 pg/ug | Standard Deviation 416.64 |
| Ovaprene Population, SLPI | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPa Post-Intercourse (Visit 14) | 1706.977 pg/ug | Standard Deviation 2856.2 |
| Ovaprene Population, SLPI | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | Baseline Pre-Intercourse (Visit 2) | 2640.005 pg/ug | Standard Deviation 2708.657 |
| Ovaprene Population, SLPI | Changes From Baseline in Soluble Markers of Inflammation in Cervicovaginal Fluid. | OVPb Pre-Intercourse (Visit 18) | 309.313 pg/ug | Standard Deviation 411.673 |
Other Pre-specified
Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Absence of the Study Device.
Evaluating the change in CVF pH before and after sex with no device present.
Time frame: Pre-Intercourse (Baseline Visit 1) and Post-Intercourse (Baseline Visit 2) (24hrs)
Population: There were 7 subjects that did not have an evaluable result for pH in Cervicovaginal Fluid at these timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ovaprene Population | Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Absence of the Study Device. | Pre-Intercourse Visit 1 | 6.42 pH | Standard Deviation 0.804 |
| Ovaprene Population | Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Absence of the Study Device. | Post-Intercourse Visit 2 | 6.92 pH | Standard Deviation 0.417 |
Other Pre-specified
Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device.
Evaluating the change in CVF pH before and after intercourse when the Ovaprene device was being worn during intercourse.
Time frame: OVP Cycle A Visit 13 (Day 121) to Visit 14 (Day 122) and OVP Cycle B Visit 18 (Day 156) to Visit 19 (Day 157).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ovaprene Population | Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device. | Pre-Intercourse Visit 13 (A) Visit 18 (B) | 6.15 pH | Standard Deviation 1.147 |
| Ovaprene Population | Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device. | Post-Intercourse Visit 14 (A); Visit 19 (B) | 6.57 pH | Standard Deviation 0.89 |
| Ovaprene Population, PCT B | Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device. | Pre-Intercourse Visit 13 (A) Visit 18 (B) | 5.94 pH | Standard Deviation 1.266 |
| Ovaprene Population, PCT B | Changes in Cervicovaginal pH Pre-coitus and Post-coitus in the Presence of the Study Device. | Post-Intercourse Visit 14 (A); Visit 19 (B) | 6.40 pH | Standard Deviation 1.011 |
Other Pre-specified
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) During Use of the Device.
Number of participants within the Ovaprene population that experienced a Urogenital treatment emergent adverse event (AE).
Time frame: 175 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovaprene Population | Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) During Use of the Device. | 21 Participants |
Other Pre-specified
Location of Ovaprene in Relation to Cervix
Location was determined digitally and visually by the investigators.
Time frame: 175 days
Population: The examinations at Screening were amended to occur at BP3, so later participants only had a check at BP3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovaprene Population | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 15 Participants |
| Ovaprene Population | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 15 Participants |
| Ovaprene Population | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population, PCT B | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population, PCT B | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 17 Participants |
| Ovaprene Population, PCT B | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 17 Participants |
| Ovaprene Population, PCT B | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population, PCT B | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population, PCT B | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population, SLPI | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 21 Participants |
| Ovaprene Population, SLPI | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population, SLPI | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population, SLPI | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 21 Participants |
| Ovaprene Population, SLPI | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population, SLPI | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 33 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 33 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 2 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 29 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 30 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 1 Participants |
| Ovaprene Population at Unscheduled Visit | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 1 Participants |
| Ovaprene Population at Unscheduled Visit | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 26 Participants |
| Ovaprene Population at Unscheduled Visit | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 26 Participants |
| Ovaprene Population at Unscheduled Visit | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at Unscheduled Visit | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at Unscheduled Visit | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OS5 | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OS5 | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OS5 | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OS5 | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 28 Participants |
| Ovaprene Population at OS5 | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 28 Participants |
| Ovaprene Population at OS5 | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1A | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1A | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 26 Participants |
| Ovaprene Population at OP1A | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1A | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 26 Participants |
| Ovaprene Population at OP1A | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1A | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 25 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 25 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 2 Participants |
| Ovaprene Population at OP2A | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 2 Participants |
| Ovaprene Population at OP3A | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 2 Participants |
| Ovaprene Population at OP3A | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP3A | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP3A | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 24 Participants |
| Ovaprene Population at OP3A | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 2 Participants |
| Ovaprene Population at OP3A | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 24 Participants |
| Ovaprene Population at OP4A | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP4A | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP4A | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP4A | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 25 Participants |
| Ovaprene Population at OP4A | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP4A | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 25 Participants |
| Ovaprene Population at OP5A | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP5A | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP5A | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 23 Participants |
| Ovaprene Population at OP5A | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP5A | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP5A | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 23 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 23 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP1B | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 23 Participants |
| Ovaprene Population At OP2B | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population At OP2B | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population At OP2B | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 24 Participants |
| Ovaprene Population At OP2B | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 24 Participants |
| Ovaprene Population At OP2B | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population At OP2B | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP3B | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP3B | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 24 Participants |
| Ovaprene Population at OP3B | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP3B | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 23 Participants |
| Ovaprene Population at OP3B | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP3B | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP4B | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP4B | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP4B | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 24 Participants |
| Ovaprene Population at OP4B | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 24 Participants |
| Ovaprene Population at OP4B | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP4B | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 0 Participants |
| Ovaprene Population at OP5B | Location of Ovaprene in Relation to Cervix | Digital: Not over cervical os/not on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP5B | Location of Ovaprene in Relation to Cervix | Digital: not over cervical os - on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP5B | Location of Ovaprene in Relation to Cervix | Visual: not over cervical os - on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP5B | Location of Ovaprene in Relation to Cervix | Digital Exam: Over cervical os | 22 Participants |
| Ovaprene Population at OP5B | Location of Ovaprene in Relation to Cervix | Visual: Not over cervical os/not on anterior vaginal wall | 1 Participants |
| Ovaprene Population at OP5B | Location of Ovaprene in Relation to Cervix | Visual: Over cervical os | 22 Participants |
Other Pre-specified
Number of Devices With Presence of Group A Streptococcus That Have Been Worn for One Cycle.
Vaginal samples and swabs of the used Ovaprene devices were tested for group A Streptococcus.
Time frame: 35 days (one full cyle)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovaprene Population | Number of Devices With Presence of Group A Streptococcus That Have Been Worn for One Cycle. | 0 Participants |
Other Pre-specified
Number of Participants With a Study Devices That Has Been Worn for One Cycle With Staphylococcus Aureus Presence on Study Device.
Vaginal samples and swabs of the used Ovaprene devices were tested for growth of staphylococcus aureus.
Time frame: 35 days (one complete cycle)
Population: Analysis was performed on rings worn for one full cycle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovaprene Population | Number of Participants With a Study Devices That Has Been Worn for One Cycle With Staphylococcus Aureus Presence on Study Device. | 0 Participants |
Other Pre-specified
Number of Participants With Changes in Pelvic Exam Findings From Baseline
Pelvic exams were completed at all 21 visits via a vaginal Colposcopy procedure.
Time frame: 175 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovaprene Population | Number of Participants With Changes in Pelvic Exam Findings From Baseline | 0 Participants |
Other Pre-specified
Participants That Could Correctly Insert, Position and Remove the Ovaprene Device
Number of participants that required written instructions, those who required written and verbal instructions and those who needed physical assistance.
Time frame: Visit 3 (BP3, Day 15-20); Visit 7 (OS1, Day 84); Visit 12 (OP1a, Day 112); Visit 13 (OP2a, Day 122-132); Visit 17 (OP1b, Day 140); UNS could occur at any point during the 175 day study duration
Population: The sites were reminded during a site call on 2/11/2019 that they were to allow patients to try to insert, position, and remove the device using only written instructions. After that point, there were 20 patients who were given the opportunity to do this. Not all participants attempted this at all visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written and verbal instructions | 4 Participants |
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - physical assistance required | 0 Participants |
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - physical assistance needed | 0 Participants |
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - physical assistance required | 0 Participants |
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written only | 11 Participants |
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written and verbal instructions | 3 Participants |
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written and verbal instructions | 2 Participants |
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written only | 13 Participants |
| Ovaprene Population | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written only | 12 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - physical assistance required | 0 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - physical assistance required | 0 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written and verbal instructions | 0 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - physical assistance needed | 0 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written only | 12 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written and verbal instructions | 0 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written only | 11 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written only | 9 Participants |
| Ovaprene Population, PCT B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written and verbal instructions | 1 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written and verbal instructions | 0 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - physical assistance required | 0 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written only | 12 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written and verbal instructions | 0 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - physical assistance required | 0 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - physical assistance needed | 0 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written only | 0 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written and verbal instructions | 0 Participants |
| Ovaprene Population, SLPI | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written only | 12 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - physical assistance required | 0 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written only | 1 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written and verbal instructions | 0 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - physical assistance needed | 0 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written only | 1 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written and verbal instructions | 0 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written only | 0 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written and verbal instructions | 0 Participants |
| Ovaprene Population at OP2A | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - physical assistance required | 0 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written and verbal instructions | 0 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written only | 13 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written only | 9 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - physical assistance needed | 0 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - physical assistance required | 0 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written and verbal instructions | 0 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written and verbal instructions | 0 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written only | 13 Participants |
| Ovaprene Population at OP1B | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - physical assistance required | 0 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written only | 1 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written only | 1 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - physical assistance required | 0 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - physical assistance required | 0 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written and verbal instructions | 0 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Remove - written only | 1 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - physical assistance needed | 0 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Position - written and verbal instructions | 0 Participants |
| Ovaprene Population at Unscheduled Visit | Participants That Could Correctly Insert, Position and Remove the Ovaprene Device | Insert - written and verbal instructions | 0 Participants |
Other Pre-specified
Participants Who Could be Fitted With the Ovaprene Device
Time frame: Screening or BP3 Visit (2 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovaprene Population | Participants Who Could be Fitted With the Ovaprene Device | 32 Participants |
Other Pre-specified
Summary of the Acceptability of the Study Device Among Male and Female Participants.
Summary of Open-Ended Acceptability Questionnaire
Time frame: 175 days
Population: Each participant could answer the questionnaire 3 times, one for each Ovaprene cycle therefore one participant could have made the same comment 3 times. The results display the number of times a comment was made.~All comments were pooled together in this table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Not Pericoital | 29 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Easy to use/insert/convenient | 48 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Does not slip out | 2 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | At home removal and insertion | 2 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Comfortable/cannot tell it is there | 52 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Lack of side effects | 9 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Hormone-free | 32 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Discreet, small, light, soft | 17 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Altruism | 4 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Iron supplementation | 1 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Easy for the doctor to take out and put back in | 1 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | Learning about how my body changes through different cycles | 1 participant comments |
| Ovaprene Population | Summary of the Acceptability of the Study Device Among Male and Female Participants. | I believe its effective | 1 participant comments |