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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00614406
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : July 4, 2012
Last Update Posted : December 13, 2012
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovulation (Follicular Rupture Yes/no) Menstrual Cycles (Total Length, Bleeding Days) Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P) Drug: Celebrex Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.
Study Start Date : January 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation
Drug Information available for: Celecoxib

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Celebrex
One 400mg tablet daily.
Placebo Comparator: 2 Drug: Placebo
One tablet daily.


Outcome Measures
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Primary Outcome Measures :
  1. Menstrual Cycle Length [ Time Frame: 3 months ]
    Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614406


Locations
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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
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Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
More Information
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Additional Information:

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Responsible Party: Alison Edelman, MD, MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00614406    
Other Study ID Numbers: OHSU FAMPLAN 3854
First Posted: February 13, 2008    Key Record Dates
Results First Posted: July 4, 2012
Last Update Posted: December 13, 2012
Last Verified: December 2012
Keywords provided by Alison Edelman, Oregon Health and Science University:
Celebrex
prostaglandin inhibitor
ovulation
menstrual cycles
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action