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NCT03440359 · ClinicalTrials.gov registry record · Phase 2
Vaginal Progesterone Supplementation in Women With PCOS Undergoing Ovulation Induction With Letrozole
A Phase 2 study, sponsored by Eastern Virginia Medical School.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT03440359 is a Phase 2 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 52 participants.
The verdict
NCT03440359, a Phase 2 study, has completed, sponsored by Eastern Virginia Medical School.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
Aromatase inhibitors such as letrozole are hypothesized to maintain normal hypothalamic/ pituitary feedback mechanisms and in the case of OI (ovulation induction) in women with PCOS, may act to increase follicular sensitivity to FSH by increasing intrafollicular androgen levels. Letrozole also may act to increase midluteal P levels presumably by induction of follicles and corpora lutea. The investigators are asking the question whether P supplementation with Crinone (8%) may have an additive beneficial effect on endometrial development in those women taking letrozole. Progesterone levels in the endometrium (tissue levels) have been documented to be significantly higher than serum levels after vaginal administration which may lead to higher pregnancy rates. In addition P has been shown to decrease LH pulse frequency which is elevated in PCOS and has been shown to down regulate endometrial androgen receptors. There have been retrospective studies showing progesterone supplementation seems to benefit both CC and letrozole treatment groups. In fact, this study showed the only pregnancies in the letrozole group were those in women who took P supplementation. However the number of cycles studied was small. There is a place for a randomized controlled trial (RCT) to determine if luteal phase P supplementation with Crinone should be used in all women using letrozole for Ovulation Induction (OI) in combination with Intrauterine Insemination (IUI) or Timed Intercourse (TI). This is currently not done in all clinical practices.
Interventions
- DRUG Letrozole Oral Tablet
- DRUG Progesterone Vaginal Gel 8%
- DIAGNOSTIC_TEST pelvic ultrasound
- DRUG Ovidrel 250 MCG Per 0.5 ML Prefilled Syringe
- OTHER Intrauterine insemination or timed intercourse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-07-06 |
| Est. Completion | 2017-12-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03440359
The ClinicalTrials.gov registry entry for NCT03440359 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eastern Virginia Medical School, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Letrozole Oral Tablet is the first listed.
NCT03440359 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03440359 about?
NCT03440359 is a clinical study titled "Vaginal Progesterone Supplementation in Women With PCOS Undergoing Ovulation Induction With Letrozole". Aromatase inhibitors such as letrozole are hypothesized to maintain normal hypothalamic/ pituitary feedback mechanisms and in the case of OI (ovulation induction) in women with PCOS, may act to increase follicular sensitivity to FSH by increasing intrafollicular androgen levels. Letrozole also may a...
What is the current status of trial NCT03440359?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2012-07-06. Estimated completion is 2017-12-30.
What interventions are being tested in trial NCT03440359?
The interventions under investigation include: Letrozole Oral Tablet (DRUG), Progesterone Vaginal Gel 8% (DRUG), pelvic ultrasound (DIAGNOSTIC_TEST), Ovidrel 250 MCG Per 0.5 ML Prefilled Syringe (DRUG), Intrauterine insemination or timed intercourse (OTHER).
Who is sponsoring clinical trial NCT03440359?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
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