Phase 4 Completed N=10 Triple-blind Diagnostic

The Role of Estrogen in Luteinizing Hormone Surge and Ovulation

Ovulation disorder · Ovarian Cysts

Source: ClinicalTrials.gov NCT01999569 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcomePrimary: Number of Participants With Progesterone Level Greater Than 1.5 ng/mL — 9; 10 Participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.