Contraception
Conditions
Brief summary
This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use.
Detailed description
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate the effectiveness, PK, safety, and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) rather than the currently prescribed 3-month (12-14 weeks) regimen. A total of 750 healthy, sexually active women aged 18 to 35 years with regular menstrual cycles and no DMPA use in the previous 12 months will be enrolled and followed for pregnancy. Among all enrolled, 710 will be randomized to receive injections in the abdomen or upper thigh in accordance with the PATH Sayana® injection instructions, which are consistent with prescribing information, for the primary effectiveness analysis. An additional 40 women will be randomized to receive injections subcutaneously in the back of the upper arm to assess whether differences in PK may exist which could impact the grace period for reinjections for that injection site. A single MPA serum sample will be collected from all participants at baseline. All participants will receive re-injections at month 4 and month 8, and complete their scheduled follow-up at month 12. There will be a plus 7-day grace period for re-injections, but women who are up to 28 days late may continue treatment if they have a negative urine pregnancy test. Urine pregnancy testing will be performed at month 4, at study exit and at any other time during the study if clinically indicated. Participants will be evaluated for injection site reactions and asked to provide information on adverse events, prohibited concomitant medication and other contraceptive use, vaginal bleeding, and method acceptability at all regular follow-up visits (i.e., not including the PK visits at Months 2 and 3). Serious adverse events and adverse events leading to product withdrawal, will be recorded throughout the study.
Interventions
DRUGSayana® Press
The active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection.
Sponsors
FHI 360
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Neither participants nor site staff will be blinded to SC injection sites. However, laboratory staff analyzing serum MPA specimens and staff at FHI 360 responsible for adjudicating pregnancy outcomes and coding adverse events will be blinded to individual participant injection site assignments for the duration of each participant's follow up.
Intervention model description
All participants will receive the same study drug, Sayana® Press. However, women will be randomized to receive their injections in the abdomen, back of the upper arm, or upper thigh to control for potential confounding when assessing relationships between SC injection site, efficacy, and PK. One cohort of N=630 women will be randomized 1:1 to receive their injections in the abdomen or thigh, and a separate PK cohort of N=120 women agreeing to MPA testing will be randomized 1:1:1 to receive their injections in the abdomen, upper thigh, or back of the upper arm. Randomization will be stratified by cohort and site using appropriate randomly permuted block sizes.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* not pregnant and no desire to become pregnant in the next 18 months * regular menstrual cycles (25 to 35 days in length when not using hormonal contraception, pregnant, or lactating) * at risk of pregnancy (no diagnosis of infertility, no history of tubal ligation or hysterectomy, and an average of 1 or more unprotected acts of vaginal intercourse per month) * in good general health as determined by a medical history * 18 to 35 years of age, inclusive * willing to provide informed consent, follow all study requirements, and rely on Sayana® Press injected every 4 months as the only means of contraception for 12 months * has only one sexual partner and expects to have that same sexual partner for the next 12 months
Exclusion criteria
* has a primary partner who has received a vasectomy or is otherwise sterile * medical contraindications to depot medroxyprogesterone acetate (DMPA) per World Health Organization medical eligibility criteria for contraceptive use * known HIV-infection (for her or her partner) * diagnosis or treatment for a sexually transmitted infection in the past month (for her or a partner), excluding recurrent herpes or condyloma * received an injection of a progestin-only containing contraceptive (DMPA or norethisterone enanthate) in the past 12 months * received an injection of a combined injectable contraceptive in the past 6 months * known or suspected allergic reaction to DMPA * used a levonorgestrel-releasing intrauterine system, NuvaRing, contraceptive patch, oral contraceptives or a contraceptive implant in the 7 days prior to enrollment (PK cohort only) * previous (within 1 month prior to enrollment), current or planned (in the next 12 months) use of an investigational drug, prohibited drug per protocol or other drug which in the opinion of the site investigator could complicate study findings * has been pregnant in the past month * is lactating * plans to move to another location in the next 12 months * has a social or medical condition which in the opinion of the site investigator would make study participation unsafe, or interfere with adherence to protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Pregnancy | 12 months after treatment initiation | Pregnancy is defined as having a positive urine pregnancy test. Positive urine tests will be confirmed by ultrasound and/or serum hCG testing whenever possible. The primary efficacy analysis will be based on the pregnancy Pearl Index, computed as the number of pregnancies that occur during the treatment period multiplied by 100 and divided by the number of WY of treatment contributed to the Treated Analysis Set among women receiving injections in the abdomen or thigh. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum MPA Concentrations in a Subset of 120 Participants | 2, 3, 4, 8, and 12 months after treatment initiation | Pharmacokinetic endpoints include serum MPA concentrations at month 2, 3, 4, 8, and 12. |
| Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | 12 months after treatment initiation | The overall safety of study drug will be assessed throughout the study by evaluating the occurrence of SAEs and AEs leading to product discontinuation, blood pressure and weight at regularly scheduled visits, and changes in bleeding pattern. |
| Acceptability of Sayana® Press | 12 months after treatment initiation | Perception of bleeding patterns and other responses to acceptability questions will be summarized using descriptive statistics based on routine questions asked at regularly scheduled visits (enrollment, months 4 and 8, and final). Acceptability data collected during unscheduled visits are not included in this table. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months. | A maximum of 12 months from the last study injection. | Return to ovulation among a subset of study participants who received month 4 and month 8 injections and plan to use non-hormonal methods of contraception, or no contraception for up to a maximum of 12 months from the last study injection. Ovulation is defined as a single elevated serum progesterone (P ≥4.7 ng/mL) or a confirmed pregnancy test. |
Countries
Brazil, Chile, Dominican Republic
Participant flow
Recruitment details
836 Screened, 86 Not Enrolled - Medically Ineligible: 26, Declined to Enroll: 24, Ineligible due to Sexual Behavior or Recent Contraceptive Use: 19, Unable to Comply with Study Req.:15, Investigator Discretion: 2
Participants by arm
| Arm | Count |
|---|---|
| Abdomen Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months).
Sayana® Press: The active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection. | 355 |
| Upper Thigh Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months).
Sayana® Press: The active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection. | 355 |
| Back of the Upper Arm Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) injected subcutaneously every 4 months (17-18 weeks) for 3 treatment cycles (12 months).
Sayana® Press: The active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection. | 40 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 11 | 0 |
| Overall Study | Physician Decision | 13 | 6 | 0 |
| Overall Study | Protocol Violation | 3 | 5 | 0 |
| Overall Study | Withdrawal by Subject | 49 | 55 | 8 |
Baseline characteristics
| Characteristic | Abdomen | Upper Thigh | Back of the Upper Arm | Total |
|---|---|---|---|---|
| Age, Customized participants18-29 years | 266 Participants | 273 Participants | 31 Participants | 570 Participants |
| Age, Customized participants 30-40 years | 89 Participants | 82 Participants | 9 Participants | 180 Participants |
| Average times have vaginal sex per month with male partner | 12.1 Events per month STANDARD_DEVIATION 7.27 | 11.9 Events per month STANDARD_DEVIATION 8.09 | 10.2 Events per month STANDARD_DEVIATION 6.23 | 11.9 Events per month STANDARD_DEVIATION 7.62 |
| Education Participants ≤9 years | 94 Participants | 91 Participants | 7 Participants | 192 Participants |
| Education Participants >9 years | 261 Participants | 264 Participants | 33 Participants | 558 Participants |
| Height | 160.7 cm STANDARD_DEVIATION 5.98 | 160.5 cm STANDARD_DEVIATION 6.7 | 160.6 cm STANDARD_DEVIATION 6.38 | 160.6 cm STANDARD_DEVIATION 6.34 |
| Race/Ethnicity, Customized Bi-/Multi-racial | 223 participants | 222 participants | 19 participants | 464 participants |
| Race/Ethnicity, Customized Black | 28 participants | 29 participants | 1 participants | 58 participants |
| Race/Ethnicity, Customized White | 104 participants | 104 participants | 20 participants | 228 participants |
| Sex/Gender, Customized Female | 355 participants | 355 participants | 40 participants | 750 participants |
| Weight | 72.7 kg STANDARD_DEVIATION 18.72 | 71.1 kg STANDARD_DEVIATION 16.89 | 72.1 kg STANDARD_DEVIATION 15.21 | 71.9 kg STANDARD_DEVIATION 17.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 355 | 0 / 355 | 0 / 40 |
| other Total, other adverse events | 32 / 355 | 38 / 355 | 5 / 40 |
| serious Total, serious adverse events | 2 / 355 | 0 / 355 | 0 / 40 |
Outcome results
Primary
Occurrence of Pregnancy
Pregnancy is defined as having a positive urine pregnancy test. Positive urine tests will be confirmed by ultrasound and/or serum hCG testing whenever possible. The primary efficacy analysis will be based on the pregnancy Pearl Index, computed as the number of pregnancies that occur during the treatment period multiplied by 100 and divided by the number of WY of treatment contributed to the Treated Analysis Set among women receiving injections in the abdomen or thigh.
Time frame: 12 months after treatment initiation
Population: The primary study objective is to evaluate the effectiveness of Sayana® Press when injected subcutaneously every 4 months among women in the Treated Analysis set who received injections in the abdomen or upper thigh. This outcome measure was pre-specified to only assess participants who were injected in the abdomen and upper thigh.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdomen | Occurrence of Pregnancy | 0 Pregnancies per 100 women years |
| Upper Thigh | Occurrence of Pregnancy | 0 Pregnancies per 100 women years |
Secondary
Acceptability of Sayana® Press
Perception of bleeding patterns and other responses to acceptability questions will be summarized using descriptive statistics based on routine questions asked at regularly scheduled visits (enrollment, months 4 and 8, and final). Acceptability data collected during unscheduled visits are not included in this table.
Time frame: 12 months after treatment initiation
Population: Treated Population: Safety Analysis Set.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Abdomen | Acceptability of Sayana® Press | Would you like to use Sayana Press as a 4-month method in the future if proven effective? : Yes | 306 Participants |
| Abdomen | Acceptability of Sayana® Press | Would you like to use Sayana Press as a 4-month method in the future if proven effective? : No | 22 Participants |
| Upper Thigh | Acceptability of Sayana® Press | Would you like to use Sayana Press as a 4-month method in the future if proven effective? : Yes | 313 Participants |
| Upper Thigh | Acceptability of Sayana® Press | Would you like to use Sayana Press as a 4-month method in the future if proven effective? : No | 23 Participants |
| Back of the Upper Arm | Acceptability of Sayana® Press | Would you like to use Sayana Press as a 4-month method in the future if proven effective? : Yes | 34 Participants |
| Back of the Upper Arm | Acceptability of Sayana® Press | Would you like to use Sayana Press as a 4-month method in the future if proven effective? : No | 4 Participants |
Secondary
Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal
The overall safety of study drug will be assessed throughout the study by evaluating the occurrence of SAEs and AEs leading to product discontinuation, blood pressure and weight at regularly scheduled visits, and changes in bleeding pattern.
Time frame: 12 months after treatment initiation
Population: Whole study population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Mood altered | 1 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Weight decreased | 1 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Menstruation irregular | 9 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Libido decreased | 2 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Weight increased | 2 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Oligomenorrhoea | 1 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Headache | 1 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Pain in extremity | 0 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site discolouration | 1 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Cerebrovascular accident | 1 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Acne | 2 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Metrorrhagia | 0 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site oedema | 0 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Pelvic pain | 1 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Menometrorrhagia | 0 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site reaction | 9 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Vulvovaginal dryness | 0 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Amenorrhoea | 2 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Lower limb fracture | 1 Events |
| Abdomen | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Abdominal pain lower | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Acne | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Menstruation irregular | 14 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Abdominal pain lower | 2 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site discolouration | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site oedema | 1 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site reaction | 6 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Lower limb fracture | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Weight decreased | 3 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Weight increased | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Pain in extremity | 1 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Cerebrovascular accident | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Headache | 1 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Libido decreased | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Mood altered | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Amenorrhoea | 5 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Menometrorrhagia | 1 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Metrorrhagia | 2 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Oligomenorrhoea | 1 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Pelvic pain | 0 Events |
| Upper Thigh | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Vulvovaginal dryness | 1 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Oligomenorrhoea | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Mood altered | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site reaction | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Pelvic pain | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Amenorrhoea | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site oedema | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Acne | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Menometrorrhagia | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Injection site discolouration | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Menstruation irregular | 4 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Pain in extremity | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Metrorrhagia | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Cerebrovascular accident | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Weight increased | 1 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Abdominal pain lower | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Headache | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Weight decreased | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Vulvovaginal dryness | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Libido decreased | 0 Events |
| Back of the Upper Arm | Occurrence of Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Product Withdrawal | Lower limb fracture | 0 Events |
Secondary
Serum MPA Concentrations in a Subset of 120 Participants
Pharmacokinetic endpoints include serum MPA concentrations at month 2, 3, 4, 8, and 12.
Time frame: 2, 3, 4, 8, and 12 months after treatment initiation
Population: Subset of study participants consenting to MPA concentration analysis. Excluding participants who did not contribute blood specimens, who had baseline MPA \>0.05 ng/mL, or who required the use of more than 1 Sayana Press unit or their baseline injection. Also, the analysis set excludes any MPA specimens collected during a time when a participant reports using a concomitant medication that may impact the PK of MPA. The analysis set excludes any MPA results after an injection with more than 1 unit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abdomen | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 8 | 0.455 ng/mL | Standard Deviation 0.159 |
| Abdomen | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 4 | 0.299 ng/mL | Standard Deviation 0.131 |
| Abdomen | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 2 | 0.503 ng/mL | Standard Deviation 0.263 |
| Abdomen | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 3 | 0.367 ng/mL | Standard Deviation 0.145 |
| Abdomen | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 12 | 0.502 ng/mL | Standard Deviation 0.148 |
| Upper Thigh | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 4 | 0.267 ng/mL | Standard Deviation 0.133 |
| Upper Thigh | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 2 | 0.355 ng/mL | Standard Deviation 0.155 |
| Upper Thigh | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 3 | 0.328 ng/mL | Standard Deviation 0.16 |
| Upper Thigh | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 8 | 0.404 ng/mL | Standard Deviation 0.145 |
| Upper Thigh | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 12 | 0.431 ng/mL | Standard Deviation 0.127 |
| Back of the Upper Arm | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 12 | 0.362 ng/mL | Standard Deviation 0.155 |
| Back of the Upper Arm | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 8 | 0.305 ng/mL | Standard Deviation 0.125 |
| Back of the Upper Arm | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 2 | 0.490 ng/mL | Standard Deviation 0.264 |
| Back of the Upper Arm | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 4 | 0.248 ng/mL | Standard Deviation 0.105 |
| Back of the Upper Arm | Serum MPA Concentrations in a Subset of 120 Participants | Trough concentration at Month 3 | 0.337 ng/mL | Standard Deviation 0.18 |
Other Pre-specified
Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months.
Return to ovulation among a subset of study participants who received month 4 and month 8 injections and plan to use non-hormonal methods of contraception, or no contraception for up to a maximum of 12 months from the last study injection. Ovulation is defined as a single elevated serum progesterone (P ≥4.7 ng/mL) or a confirmed pregnancy test.
Time frame: A maximum of 12 months from the last study injection.
Population: A subset of \~20 participants at study sites in Brazil and Dominican Republic who received month 4 and month 8 injections and planned to use a non-hormonal contraceptive method, or no contraception, after study discontinuation. One participant who received an injection in the abdomen discontinued early and was censored from analysis at 41 weeks past final injection. The subset was restricted to participants included in the primary analysis, those injected in the abdomen or thigh.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Abdomen | Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months. | Women who ovulated or became pregnant by 42 weeks after final injection | 25 Percentage of participants |
| Abdomen | Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months. | Women who ovulated or became pregnant by 50 weeks after final injection | 50 Percentage of participants |
| Upper Thigh | Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months. | Women who ovulated or became pregnant by 42 weeks after final injection | 18.2 Percentage of participants |
| Upper Thigh | Return to Ovulation After 12 Months of Use of Sayana Press When Injected Every Four Months. | Women who ovulated or became pregnant by 50 weeks after final injection | 54.5 Percentage of participants |