Lower Dose Depo Provera® Contraceptive Injection

• Status: Completed
• Trial end date: 2018-05-15
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Treatments: Contraceptive Agents; Medroxyprogesterone; Medroxyprogesterone Acetate

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

• 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