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

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01129245
First received: May 21, 2010
Last updated: July 2, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover 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:


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

Primary Outcome Measures:
  • Menstrual Length When Taken After Ovulation: Extended Luteal Phase [ Time Frame: Completion of study (1 year) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

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 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
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, see Learn About Clinical Studies.

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

No publications provided by Oregon Health and Science University

Additional 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
Study First Received: May 21, 2010
Results First Received: April 7, 2014
Last Updated: July 2, 2014
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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014