Depot Medroxyprogesterone Acetate as Emergency Contraception

• Status: Completed
• Trial end date: 2020-10-30
• Target enrollment: 0
• Participant gender: Female

Summary

Background:

The prevalence of repeat unprotected intercourse after EC use in the same cycle demonstrate the need for more self-bridging emergency contraceptive options. We propose the use of intramuscular Depot Medroxyprogesterone acetate (DMPA) as EC, which has been shown to inhibit follicular activity within 24 hours, and provide on-going contraception via suppression or disruption of ovulation.

Objective:

The objective of this study is to explore the potential of depot medroxyprogesterone acetate (DMPA) given as a 150-mg intramuscular injection for use as an emergency contraceptive.

Study population:

Healthy regularly menstruating women aged 18-39 years old will be invited to participate if they fulfill inclusion criteria. The participants will undergo a screening visit during the midluteal phase of their cycle, and will be enrolled if a serum progesterone level is >3ng/ml.

Methodology:

Participants will be assigned to one of three groups based on leading follicle size. Starting cycle Day 8, transvaginal ultrasounds will be performed to assess the size of the leading follicle. Once the follicle has reached the pre-assigned size, 150 mg IM DMPA will be administered. Blood will be collected for baseline hormonal assays. For 5 consecutive days, daily blood will be drawn for hormonal assays and daily transvaginal ultrasound will be performed to assess for signs of ovulation. The participant will then return for twice weekly progesterone levels for 2 weeks for study completion.

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

Details

• Lead Sponsor: University of Southern California
• Collaborator: Society of Family Planning
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

• Healthy women of reproductive age (18-39 years old) with BMI 18-30 kg/m2

• Regular menses for the last 3 months

• Cycle duration 24 to 35 days

• Women using copper IUD, sterilization, or barrier methods as current or preferred birth control method, and women reporting exclusive sex with women

• English- or Spanish-speaking

Exclusion Criteria:

• Any contraindications to progesterone contraception per teh CDC Medical Eligibility Criteria (Category 3 or 4)

• On medications that can alter, or be altered by, progesterone contraceptive steroid hormone (e.g., aminoglutethimide or other anti-steroid medication)

• Use of any hormonal contraceptive pill, patch, or vaginal ring in the month prior to recruitment

• Use of depot-medroxyprogesterone acetate in teh 10 months prior to recruitment

• Currently pregnant and/or breastfeeding

• History of allergic reaction to depot medroxyprogesterone acetate (rash, urticaria, anaphylaxis)