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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129245
First Posted: May 24, 2010
Last Update Posted: July 16, 2014
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.
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University
  Purpose
The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.

Condition Intervention
Ovulation Luteal Development Drug: celebrex Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Menstrual Length When Taken After Ovulation: Extended Luteal Phase [ Time Frame: Completion of study (1 year) ]
    average menstrual cycle length in days during active drug exposure


Secondary Outcome Measures:
  • Change in Luteal Phase Progesterone Levels [ Time Frame: completion of study (1 year) ]
    progesterone levels during study


Enrollment: 11
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo first, then celecoxib
control menstrual cycle, placebo menstrual cycle, celecoxib cycle
Drug: celebrex
400 mg PO daily intermittently based on hormone and ultrasound findings
Other Name: celecoxib
Drug: Placebo
Other Name: identical placebo to celebrex
Experimental: Celecoxib first, then placebo
control menstrual cycle, celecoxib menstrual cycle, placebo menstrual cycle
Drug: celebrex
400 mg PO daily intermittently based on hormone and ultrasound findings
Other Name: celecoxib
Drug: Placebo
Other Name: identical placebo to celebrex

  Eligibility

Information from the National Library of Medicine

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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
  • 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 return to clinic 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 intrauterine device, abstinence, or have female partners
  Contacts and Locations
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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alison Edelman, Assistant Professor SM.OB/GYN Generalist Division, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01129245     History of Changes
Other Study ID Numbers: OHSU FAMPLAN SFP3-7
First Submitted: May 21, 2010
First Posted: May 24, 2010
Results First Submitted: April 7, 2014
Results First Posted: July 2, 2014
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Alison Edelman, 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
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