Depot Medroxyprogesterone Acetate as Emergency Contraception
NCT ID: NCT03395756
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
30 participants
INTERVENTIONAL
2018-08-31
2020-10-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Depot-Medroxyprogestereone Acetate
Administration of 150 mg intramuscular depot medroxyprogesterone acetate
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.
Depot-Medroxyprogestereone Acetate
Administration of 150 mg intramuscular depot medroxyprogesterone acetate
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.
Depot-Medroxyprogestereone Acetate
Administration of 150 mg intramuscular depot medroxyprogesterone acetate
Interventions
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Depot-Medroxyprogestereone Acetate
Administration of 150 mg intramuscular depot medroxyprogesterone acetate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
39 Years
FEMALE
Yes
Sponsors
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Society of Family Planning
OTHER
University of Southern California
OTHER
Responsible Party
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Brian T. Nguyen, MD MSc
Assistant Professor
Principal Investigators
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Robyn L Schickler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Brian Nguyen, MD, MSCP
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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University of Southern California Keck Medical Center
Los Angeles, California, United States
Countries
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References
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Other Identifiers
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HS-17-01006
Identifier Type: -
Identifier Source: org_study_id