A Study to Evaluate Suppression of Ovulation Following a Single Subcutaneous Administration of Various Doses of Depo-Provera CI
Overview
- Phase
- Phase 1
- Intervention
- Depo-Provera CI
- Conditions
- Contraception
- Sponsor
- FHI 360
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Time to ovulation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Depo-Provera CI 45 mg
a single subcutaneous (SC) injection of 45 mg/0.3 mL
Intervention: Depo-Provera CI
Depo-Provera CI 75 mg
a single subcutaneous (SC) injection of 75 mg/0.5 mL
Intervention: Depo-Provera CI
Depo-Provera CI 105 mg
a single subcutaneous (SC) injection of 105 mg/0.7 mL
Intervention: Depo-Provera CI
Depo-subQ 104
a single subcutaneous (SC) injection of 104 mg/0.65 mL
Intervention: Depo-subQ 104
Outcomes
Primary Outcomes
Time to ovulation
Time Frame: 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 Outcomes
- Measurement of serum MPA concentrations(32 weeks after receiving drug)
- Time to maximum serum concentration of MPA(32 weeks after receiving drug)
- Occurrence of adverse events(32 weeks after receiving drug)