CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 30 enrolled
Drug / intervention
Depot-Medroxyprogestereone Acetatedrug
Likely dose
Depot-Medroxyprogestereone Acetate 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03395756
NCT03395756Early Ph 1Completed

Investigation of the Potential for Intramuscular Depot Medroxyprogesterone Acetate as Emergency Contraception

University of Southern California·interventional·Posted Jan 10, 2018·Updated Nov 5, 2020

In Brief

A Early Phase 1 clinical trial evaluating Depot-Medroxyprogestereone Acetate for Emergency Contraception and Contraception. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 10, 2018
Enrollment StartAug 31, 2018
Primary CompletionOct 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.5 years ago

Interventions

Depot-Medroxyprogestereone Acetatedrug

Administration of 150 mg intramuscular depot medroxyprogesterone acetate