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NCT03106454 · ClinicalTrials.gov registry record · Phase 3
Ovulation Incidence in Oral Contraceptive Users
A Phase 3 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT03106454 is a Phase 3 study that has completed, run by University of Southern California. The registered enrollment target is 58 participants.
The verdict
NCT03106454, a Phase 3 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study Summary
Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to improve the risk profile associated with the COC. In 2010, the Food and Drug Administration approved a oral contraceptive pill containing EE 10mcg/NET acetate 1mg (Tradename Lo loestrin). However, no studies have compared this formulation to pills containing either higher doses of estrogen or progestin alone. It is not known whether EE 10mcg is sufficient to prevent follicular development or to support the endometrium as well as higher doses of EE. This trial addresses the question of whether an oral contraceptive pill with EE 10mcg/Norethindrone acetate 1mg will better suppress ovulation or have a better side effect profile than a progestin only pill with a nearly equal dose of norethindrone.
Interventions
- DRUG Ethinyl Estradiol, Norethindrone acetate, ferrous fumarate
- DRUG Norethindrone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-08 |
| Est. Completion | 2024-01-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03106454
The ClinicalTrials.gov registry entry for NCT03106454 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 58 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 2 interventions - of which Ethinyl Estradiol, Norethindrone acetate, ferrous fumarate is the first listed.
NCT03106454 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03106454 about?
NCT03106454 is a clinical study titled "Ovulation Incidence in Oral Contraceptive Users". Since the introduction of the combined hormonal contraceptive pill, dosages of ethinyl estradiol (EE) have steadily decreased from more than 150mcg to 20mcg in an attempt to improve the risk profile associated with the COC. In 2010, the Food and Drug Administration approved a oral contraceptive pill...
What is the current status of trial NCT03106454?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2014-08. Estimated completion is 2024-01-01.
What interventions are being tested in trial NCT03106454?
The interventions under investigation include: Ethinyl Estradiol, Norethindrone acetate, ferrous fumarate (DRUG), Norethindrone (DRUG).
Who is sponsoring clinical trial NCT03106454?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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