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

Not Applicable

Completed

• Conditions: Ovulation (Follicular Rupture Yes/no); Menstrual Cycles (Total Length, Bleeding Days); Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
• Interventions: Drug: Celebrex; Drug: Placebo

• Registration Number: NCT00614406
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2011-07-15
• Results First Submitted QC: 2012-06-01
• Results First Posted: 2012-07-04
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Celebrex	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Menstrual Cycle Length	3 months	Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States