The Role of Estrogen in Luteinizing Hormone Surge and Ovulation

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atrium Health; Carolinas Healthcare System
• Treatments: Estrogens; Hormones; Letrozole

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 (<26 days or >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