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

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00614406
First received: January 31, 2008
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Menstrual Cycle Length [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.


Enrollment: 11
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Celebrex
One 400mg tablet daily.
Placebo Comparator: 2 Drug: Placebo
One tablet daily.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00614406

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Alison Edelman, MD, MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00614406     History of Changes
Other Study ID Numbers: OHSU FAMPLAN 3854
Study First Received: January 31, 2008
Results First Received: July 15, 2011
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Celebrex
prostaglandin inhibitor
ovulation
menstrual cycles

Additional relevant MeSH terms:
Hemorrhage
Rupture
Pathologic Processes
Wounds and Injuries
Prostaglandin Antagonists
Celecoxib
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014