Contraception: Optional Applicator for Insertion of Vaginal Ring
Conditions
Brief summary
The purpose of the study is to assess the performance and safe use of the vaginal ring applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in healthy women
Interventions
Drug-free placebo vaginal ring
DEVICESingle-use, non-sterile applicator
Single-use, non-sterile, plastic applicator for insertion of vaginal ring.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy, non-pregnant, pre-menopausal female who is not using NuvaRing. * must meet one of the two following criteria: 1) has not taken a combined hormonal contraceptives for at least 3 months prior to screening and has normal predictable menstrual cycles ranging from 26 to 35 days in length with no history of intermenstrual bleeding in the past 6 months; or 2) has been taking a combined hormonal contraceptive for \>3 months and has not experienced unscheduled bleeding for the past 3 months. * willing to abstain from vaginal penetration, including during sexual intercourse and masturbation, from the time of randomization (Visit 2) to the end of the follow-up period. * willing to abstain from vaginal penetration with any objects other than the applicator and placebo rings (including but not limited to tampons, douching, use of vaginal applicators for medication, medication, diaphragms, cervical caps, male and female condoms, lubricants, sex toys) from the time of randomization (Visit 2) to the end of the follow-up period. * good physical and mental health, based upon the medical judgment of the investigator.
Exclusion criteria
* current use or has used within past 3 months any of the following: NuvaRing, progestin-only contraceptives (including pills, injection, or implant), oral or transdermal combined hormonal contraceptives with extended or continuous hormonal regimens that prevent monthly withdrawal bleeding by omitting monthly progestin-free intervals. Note: Current use of oral or transdermal combined hormonal contraceptives with 4 to 7 progestin-free days per 28-day cycle for \>3 months is permitted. * has stopped use of any hormonal contraceptive, including NuvaRing, \<3 months prior to screening; previous use (≥3 months prior to screening) is permitted. * history of difficulty retaining NuvaRing in the vagina and therefore could not continue on it as a contraceptive method or difficulty retaining other products (e.g., tampons) in the vagina. * is pregnant or within 2 months of last pregnancy outcome (delivery, spontaneous or induced abortion, medical or surgical management of ectopic pregnancy). * is breastfeeding. * diagnosed or treated for a sexually transmitted disease within the past 6 months. * current complaints of vaginal or vulvar irritation, discomfort, abnormal bleeding/spotting, or abnormal discharge. * abnormal cervical Pap smear documented within 12 months of screening. * genital herpes outbreak in the past 3 years. * has received any investigational drug or device in the 30 days prior to screening and/or plans to receive any investigational drug or device at any time up to the last protocol-required visit. * known current gynecological disorder which, in the opinion of the investigator, interferes with the objectives of the study. * known allergy/sensitivity or contraindication to the investigational product (applicator) or ethylene vinyl acetate. * current or recent history (within the last six months) of drug or alcohol abuse or dependence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion | Up to 48 hours after vaginal ring insertion | Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated. |
| Percentage of Participants With Successful Ring Insertion | Day 1 (immediately after vaginal ring insertion) | Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants | 164 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period 2 | Protocol Violation | 0 | 1 |
| Treatment Period 2 | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 30.2 Years STANDARD_DEVIATION 6.8 |
| Sex: Female, Male Female | 164 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 163 | 0 / 162 |
| serious Total, serious adverse events | 0 / 163 | 0 / 162 |
Outcome results
Primary
Percentage of Participants With Successful Ring Insertion
Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.
Time frame: Day 1 (immediately after vaginal ring insertion)
Population: Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Applicator | Percentage of Participants With Successful Ring Insertion | 100 Percentage of participants |
| No Applicator (Manual) | Percentage of Participants With Successful Ring Insertion | 100 Percentage of participants |
Primary
Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion
Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.
Time frame: Up to 48 hours after vaginal ring insertion
Population: Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Applicator | Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion | 0 Percentage of participants |
| No Applicator (Manual) | Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion | 0 Percentage of participants |