The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle

Oregon Health and Science University11 enrolled

Overview

The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.

Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Ovulation (Follicular Rupture Yes/no)Menstrual Cycles (Total Length, Bleeding Days)Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)

Interventions

CelebrexDRUG

One 400mg tablet daily.

PlaceboDRUG

One tablet daily.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-35 * Normal menstrual periods (24-35 days) * Good general health * Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence) * Willing and able to return to clinic for bi-weekly blood tests Exclusion Criteria: * Pregnant or breast feeding * Polycystic ovarian disease * Gastrointestinal conditions (i.e.gastric ulcer) * Currently using birth control * Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs * Diabetes * Cardiac disease or hypertension * Moderate to severe heartburn (GERD) * Obesity (BMI greater than 30)

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Menstrual Cycle Length

Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.

Time frame: 3 months

Data from ClinicalTrials.gov

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