Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

Pharmacodynamics (Suppression of Ovulation) and Pharmacokinetics Following a Single Subcutaneous Administration of Depo Provera® CI 150 mg/mL, Depo Provera® CI 300 mg/2 mL, or During Two Cycles of Depo-subQ Provera 104®

This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

This is a randomized, multi-center, parallel-group Phase I study with a primary objective to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150mg/mL or 300mg/2mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

Secondary study objectives are:

• To evaluate and compare the pharmacokinetics (PK) of MPA after a single SC injection of 150mg/mL or 300mg/2mL of Depo-Provera CI to two injections of Depo-subQ 104 administered 3 months apart
• To evaluate the relationship between serum MPA concentration and suppression of ovulation
• To evaluate and compare the safety, tolerability and acceptability of a SC injection of DMPA of different frequencies, doses and volumes

inclusion

Women may be included in the study if they meet all of the following criteria:

• in good general health
• age 18 to 40 years, inclusive
• willing to provide informed consent and follow all study requirements
• not pregnant
• does not desire to become pregnant in the next 24 months
• regular menstrual cycle (24 to 35 days)
• confirmed ovulation by serum P ≥ 4.7 ng/mL in two consecutive samples during the pre-treatment phase of the study
• at low risk of pregnancy (e.g., sterilized, in exclusively same sex partnership, in monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD or condoms)
• has a body mass index of 18.0 to 35.0
• has hemoglobin ≥10.5 g/L

exclusion

Women will be excluded from participating in this study if they meet any of the following criteria:

• medical contraindications to DMPA use

• use of any of the following medications within 1 month prior to enrollment:

  • any investigational drug
  • prohibited drugs (per protocol)
  • oral contraceptives
  • LNG IUS or implant

• use of DMPA in the past 12 months

• use of a combined injectable contraceptive in the past 6 months

• recent pregnancy (within 3 months)

• current lactation

• ongoing or anticipated use of prohibited drugs (per protocol)

• known sensitivity to MPA

• plan to move to another location in the next 18 months

• any condition (social or medical) which in the opinion of the site investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation.