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
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sensiti…