Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

• Status: Completed
• Trial end date: 2018-08-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: FHI 360
• Collaborators: Asociación Dominicana Pro Bienestar de la Familia, Inc.; Oregon Health and Science University
• Treatments: Contraceptive Agents; Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

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.