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

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Celebrex; One 400mg tablet daily.
Placebo Comparator: 2	Drug: Placebo; One tablet daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual Cycle Length	Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.	3 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Alison Edelman, MD, MPH, Oregon Health and Science University

Publications and helpful links

Helpful Links

• OHSU Women's Health Research Unit

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: January 31, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Estimate): December 13, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Celebrex; prostaglandin inhibitor; ovulation; menstrual cycles
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: OHSU FAMPLAN 3854