Phase 4
N=10
The Role of Estrogen in Luteinizing Hormone Surge and Ovulation
Ovulation Disorder · Ovarian Cysts
Bottom Line
View on ClinicalTrials.gov: NCT01999569 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants With Progesterone Level Greater Than 1.5 ng/mL — 9; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Letrozole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progesterone Level Greater Than 1.5 ng/mL |
9; 10 | — |
| SECONDARY Number of Participants With a Positive LH Test |
9; 10 | — |
| SECONDARY Number of Participants With Follicular Development |
10; 10 | — |
Summary
The purpose of the study is to establish that sustained estrogen levels are the driving force for the LH surge, and are thereby necessary for ovulation to occur. We predict that by reducing levels of circulating estrogen, letrozole, an aromatase inhibitor, will inhibit ovulation from occurring.
Eligibility Criteria
Inclusion Criteria
- Patient having regular menstrual cycles between 26-30 days
- Ages 18-40
- Patient must not be sexually active during the study period, or if so must be using a reliable form of non-hormonal birth control including tubal ligation or vasectomy, non-hormonal intrauterine contraceptive device (IUD), or condoms with spermicide.
- Willing to participate in study and available for all monitoring visits.
- IRB consent
Exclusion Criteria
- Patient must NOT have used hormonal contraception three months or less prior to study.
- Irregular menstrual cycles ( 30 days within the last 6 months.
- Untreated thyroid dysfunction or hyperprolactinemia
- Pregnancy (current or within 3 months) or breastfeeding
- Allergy or contraindication to letrozole
Data sourced from ClinicalTrials.gov (NCT01999569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.