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

This study is currently recruiting participants.

Verified by Oregon Health and Science University, December 2007

Sponsors and Collaborators:	Oregon Health and Science University Society of Family Planning
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00614406

Purpose

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

Condition	Intervention
Ovulation Menstrual Cycles	Drug: Celebrex Drug: Placebo

MedlinePlus related topics: Menstruation

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.

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

Primary Outcome Measures:

Progesterone levels [ Time Frame: Completion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Menstrual cycle length [ Time Frame: Study completion ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Celebrex One 400mg tablet daily.
2: Placebo Comparator	Drug: Placebo One tablet daily.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614406

Contacts

Contact: Women's Health Research Confidential Recruitment Line

503 494-3666

whru@ohsu.edu

Locations

United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Sub-Investigator: Jeffrey Jensen, MD, MPH
Principal Investigator: Alison Edelman, MD, MPH
Sub-Investigator: Marcella Messerle Forbes, FNP
Sub-Investigator: Andrea O'Donnell, FNP
Sub-Investigator: Mark Nichols, MD
Sub-Investigator: Paula Bednarek, MD, MPH
Sub-Investigator: Michelle Isley, MD

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

OHSU Women's Health Research Unit This link exits the ClinicalTrials.gov site

Responsible Party:	OHSU ( Alison Edelman, MD, MPH )
Study ID Numbers:	OHSU FAMPLAN 3854
Study First Received:	January 31, 2008
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00614406
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Celebrex
prostaglandin inhibitor
ovulation
menstrual cycles

Study placed in the following topic categories:

Celecoxib

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009