Depot Medroxyprogesterone Acetate as Emergency Contraception

November 3, 2020 updated by: Brian T. Nguyen, MD MSc, University of Southern California

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study will enroll 36 healthy, non-pregnant, non-breastfeeding, reproductive age women with regular ovulatory cycles. Potential participants will undergo screening, which will include a history, physical exam, assessment of vital signs, and blood draw for assessment of ovulation via mid-luteal progesterone levels. If her progesterone level confirms ovulatory status (> 3 ng/ml), she will be offered enrollment and assigned to one of three follicular phase groups based on her leading follicle size in the next cycle: 12-14 mm, 15-17 mm, and ≥18 mm. To determine follicle size, participants will receive serial transvaginal ultrasound (TVUS) scans of their ovarian follicles starting on cycle day 8 of the next menstrual cycle. The scans will be performed three times weekly to identify her leading follicle. Once the leading follicle has reached its assigned size, DMPA will be administered. Blood samples will be obtained prior to administration for baseline hormonal assays. One hour after administration, blood will be drawn for MPA levels. For the following five consecutive days, the participant will undergo daily TVUS to detect signs of follicular rupture and blood draws to assess serum markers of ovulation (estradiol, progesterone, and luteinizing hormone). On the first day, 24 hours after DMPA administration, blood will be drawn for MPA levels as well. After five days, the participant will return twice weekly for two weeks to provide serum progesterone levels to detect any delayed ovulation or ovulatory dysfunction. At the final visit, she will fill out a simple survey to assess her satisfaction with DMPA as an EC method, and whether she would recommend this method to others.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California Keck Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 12-14 mm follicle size group
Once the participant's leading follicle reaches 12-14mm, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels.
Drug: Depot-Medroxyprogestereone Acetate
Administration of 150 mg intramuscular depot medroxyprogesterone acetate
Active Comparator: 15-17 mm follicle size group
Once the participant's leading follicle reaches 15-17mm, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels.
Drug: Depot-Medroxyprogestereone Acetate
Administration of 150 mg intramuscular depot medroxyprogesterone acetate
Active Comparator: 18 mm or greater follicle size group
Once the participant's leading follicle reaches 18mm or greater, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels.
Drug: Depot-Medroxyprogestereone Acetate
Administration of 150 mg intramuscular depot medroxyprogesterone acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation
Time Frame: 5 days to 3 weeks
Follicle rupture on ultrasound preceded by LH surge 21 IU/L or greater, followed by progesterone level 3 ng/ml or greater.
5 days to 3 weeks
Ovulation Suppression
Time Frame: 5 days to 3 weeks
Lack of follicular rupture on ultrasound with or without appropriate LH surge of 21 IU/L or greater and without elevation in progesterone levels to 3 ng/ml or greater
5 days to 3 weeks
Ovulatory dysfunction
Time Frame: 5 days to 3 weeks
Rupture of leading follicle without appropriate LH surge (less than 21 IU/L) and without appropriate progesterone elevation after rupture (less then 3 ng/ml)
5 days to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Robyn L Schickler, MD, University of Southern California
  • Principal Investigator: Brian Nguyen, MD, MSCP, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2018

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-17-01006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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