The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation

This study is ongoing, but not recruiting participants.

First Received on May 21, 2010. Last Updated on August 3, 2011 History of Changes

Sponsor:	Oregon Health and Science University
Collaborator:	Society of Family Planning
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT01129245

Purpose

The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug {NSAID}) has on ovulation.

Condition	Intervention
Ovulation Luteal Development	Drug: celebrex

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Official Title:	The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation

Resource links provided by NLM:

Drug Information available for: Celecoxib

U.S. FDA Resources

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

Primary Outcome Measures:

When taken before ovulation: blocking ovulation When taken after ovulation: extended luteal phase [ Time Frame: Completion of study (1 year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

When taken before ovulation: delaying ovulation When taken after ovulation: premature onset of menses [ Time Frame: completion of study (1 year) ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Celebrex receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results	Drug: celebrex 400 mg PO daily intermittently based on hormone and ultrasound findings Other Name: celecoxib

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
Currently NOT using hormonal contraception
Cycle length between 26-34 days
General good health (specifically no hx of: diabetes, cardiac problems, moderate/severe heart burn (GERD), obesity (BMI > 30), hypertension (BP > 130/80)
Willing and able to agree to randomization and informed consent
Willing and able to use a menstrual diary to chart bleeding Serum progesterone > 3 ng/ml (from cycle day 18-25)
Willing and able to RTC for bi-weekly for blood tests and ultrasounds throughout cycles 2, 3 & 5

Exclusion Criteria:

Diabetes
Cardiac disease
Moderate to severe heart burn (or GERD) Obesity (BMI > 30) Hypertension (BP > 130/80)
Allergy to NSAIDS
Currently pregnant or trying to conceive
Polycystic Ovarian Syndrome
Use of hormonal contraception (participants can use barrier methods, spermicide, female or male sterilization, copper IUD, abstinence, or have female partners

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129245

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

Additional Information:

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

No publications provided

Responsible Party:	Alison Edelman, MD, MPH, OHSU
ClinicalTrials.gov Identifier:	NCT01129245 History of Changes
Other Study ID Numbers:	OHSU FAMPLAN SFP3-7
Study First Received:	May 21, 2010
Last Updated:	August 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Celebrex
prostoglandin inhibitor
ovulation
emergency contraception

Additional relevant MeSH terms:

Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2012