Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods (NCT02456584) | Clinical Trial Compass
CompletedPhase 1
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
United States, Dominican Republic42 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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 adher…