Depot Medroxyprogesterone Acetate as Emergency Contraception
Condition: Emergency Contraception; Contraception
MeSH terms: Emergencies
Study type: Interventional
Phase: Early Phase 1

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.
    

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.
    

Intervention name(s): Depot-Medroxyprogestereone Acetate
Intervention type(s): Drug
Intervention description(s): Administration of 150 mg intramuscular depot medroxyprogesterone acetate
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: Depot Medroxyprogesterone acetate; Injectable birth control