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

May 24, 2019 updated by: Alison Edelman, Oregon Health and Science University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2). Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the above treatment schemes and received the other in the subsequent treatment cycle.

This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib, would be a more effective agent in terms of causing ovulatory dysfunction. This study also aims to determine whether treatment with celecoxib would adversely affect luteal function.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control cycle
Control menstrual cycle
Experimental: Pre-LH surge celecoxib administration
Pre-LH surge dosing of celecoxib
Drug: Celebrex
400 mg PO daily intermittently based on hormone and ultrasound findings
Other Names:
  • Celecoxib
Drug: Placebo
Placebo identical to celecoxib
Experimental: Post-LH surge celecoxib administration
Post-LH surge dosing of celecoxib
Drug: Celebrex
400 mg PO daily intermittently based on hormone and ultrasound findings
Other Names:
  • Celecoxib
Drug: Placebo
Placebo identical to celecoxib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase
Time Frame: 4 cycles (approximately 4 months)
One cycle corresponds to one participant
4 cycles (approximately 4 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Hormone Levels
Time Frame: 4 cycles (approximately 4 months)
Average serum levels of progesterone (ng/mL) and luteinizing hormone (ng/mL) normalized to days of the luteal phase of menstrual cycle.
4 cycles (approximately 4 months)
Peak Estradiol Level
Time Frame: 4 cycles (approximately 4 months)
Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.
4 cycles (approximately 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Alison Edelman, MD, MPH, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHSU FAMPLAN SFP3-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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