ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01129245
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : July 2, 2014
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

Brief Summary:
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 or disease Intervention/treatment Phase
Ovulation Luteal Development Drug: celebrex Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Additional 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 Posted: May 24, 2010    Key Record Dates
Results First Posted: July 2, 2014
Last Update Posted: October 25, 2017
Last Verified: September 2017

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