Depot Medroxyprogesterone Acetate as Emergency Contraception

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Emergency Contraception, Contraception

Intervention / Treatment
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* Drug: Depot-Medroxyprogestereone Acetate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Participants in this study will be assigned to one of three groups based on leading follicle size: 12-14 mm, 15-17mm, and 18 mm or greater. Each group will receive the same medication (intramuscular depot medroxyprogesterone acetate), and be followed in the same manner for five consecutive days after administration with transvaginal ultrasound and blood draws for hormonal assays (progesterone, estradiol, and luteinizing hormone levels)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 12-14 mm follicle size group<br>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<br>* Administration of 150 mg intramuscular depot medroxyprogesterone acetate<br>|
| Active Comparator: 15-17 mm follicle size group<br>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<br>* Administration of 150 mg intramuscular depot medroxyprogesterone acetate<br>|
| Active Comparator: 18 mm or greater follicle size group<br>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<br>* Administration of 150 mg intramuscular depot medroxyprogesterone acetate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depot Medroxyprogesterone acetate, Injectable birth control