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NCT03395756 · ClinicalTrials.gov registry record · Early Phase 1
Depot Medroxyprogesterone Acetate as Emergency Contraception
A Early Phase 1 study, sponsored by University of Southern California.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT03395756 is a Early Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 30 participants.
The verdict
NCT03395756, a Early Phase 1 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG Depot-Medroxyprogestereone Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-08-31 |
| Est. Completion | 2020-10-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03395756
The ClinicalTrials.gov registry entry for NCT03395756 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Depot-Medroxyprogestereone Acetate is the first listed.
NCT03395756 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03395756 about?
NCT03395756 is a clinical study titled "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 act...
What is the current status of trial NCT03395756?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2018-08-31. Estimated completion is 2020-10-30.
What interventions are being tested in trial NCT03395756?
The interventions under investigation include: Depot-Medroxyprogestereone Acetate (DRUG).
Who is sponsoring clinical trial NCT03395756?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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