Contraception
Conditions
Keywords
CI-contraceptive injection, DMPA-Depot medroxyprogesterone acetate, MPA-Medroxyprogesterone Acetate, subQ-subcutaneous
Brief summary
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle
Detailed description
This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle. Baseline ovulation will be confirmed in all women by measuring serum progesterone (P) approximately twice a week during the 2-3 weeks preceding expected menses. Between 48 and 60 participants (12-15 per group) with confirmed ovulation who meet other eligibility criteria will be enrolled and randomized to receive a single SC injection in the abdomen of 1 of 3 doses of Depo-Provera CI: 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL or a single dose of Depo-subQ Provera (104 mg/0.65mL). Participants will be followed for 32 weeks (7.5 months) after the injection During the study participants will provide blood samples for MPA, P and estradiol (E2) prior to injection and then frequently at predefined time points through 7.5 months. In addition, for more accurate ascertainment of the PD response we will perform transvaginal ultrasound (TVS) and assess cervical mucus at predefined time points through 7.5 months. Information on adverse events and concomitant medications will be collected throughout the study. Information on acceptability will be collected at predefined time points through 7.5 months.
Interventions
DRUGDepo-Provera CI
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)
DRUGDepo-subQ 104
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA). Depo-subQ provera 104® (medroxyprogesterone acetate injectable suspension, 104 mg/0.65mL) for subcutaneous injection
Sponsors
FHI 360
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* has typical menstrual cycle of 24 to 35 days * has confirmed ovulatory cycle during the pretreatment phase (serum progesterone ≥ 4.7 ng/mL in 2 consecutive samples) * is sterilized or using non hormonal intrauterine device (IUD) * is in good general health as determined by a medical history and physical examination * 18 to 40 years of age (inclusive) * willing to provide informed consent and follow all study requirements * has negative urine pregnancy test and has no desire to become pregnant in the subsequent 12 months * has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive * has hemoglobin ≥10.5 g/dL
Exclusion criteria
* has medical contraindications to depot medroxyprogesterone acetate (DMPA) \[16\] * has undiagnosed mass in breast * used DMPA in the past 12 months * used a combined injectable contraceptive in the past 6 months * used any of the following medications within 1 month prior to enrollment: * any investigational drug * prohibited drugs per protocol * oral contraceptives * Nuva-ring * contraceptive patch * levonorgestrel intrauterine system (LNG IUS) or contraceptive implant * has been pregnant within last 3 months * Is currently lactating * in the opinion of the investigator, is potentially at elevated risk of HIV infection (HIV-positive partner, IV drug use by self or by partner) * has more than one male sexual partner * is using or plans to use prohibited drugs per protocol in the next 9 months * has known sensitivity to MPA * plans to move to another location in the next 9 months * has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements or complicate data interpretation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to ovulation | 32 weeks after receiving drug | Time to ovulation indicated by time to reach rupture of the lead follicle based on transvaginal ultrasound (TVS) findings followed by serum progesterone level of \>=4.7 ng/mL. The primary objective will be assessed by estimating the cumulative probability of return to ovulation through Month 7.5 from start of therapy in each test group based on the Kaplan-Meier product-limit method, with 95% confidence intervals derived using the complementary log-log transformation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of serum MPA concentrations | 32 weeks after receiving drug | Measure of Peak Concentrations (Cmax) |
| Time to maximum serum concentration of MPA | 32 weeks after receiving drug | Time to reach peak concentration of MPA(Tmax) |
| Occurrence of adverse events | 32 weeks after receiving drug | — |
Countries
Brazil, Chile, Dominican Republic
Outcome results
None listed