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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2011

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.

Interventions

  • Drug: Celebrex
    • 400 mg PO daily intermittently based on hormone and ultrasound findings
  • Drug: Placebo
    • Placebo identical to celecoxib

Arms, Groups and Cohorts

  • No Intervention: Control cycle
    • Control menstrual cycle
  • Experimental: Pre-LH surge celecoxib administration
    • Pre-LH surge dosing of celecoxib
  • Experimental: Post-LH surge celecoxib administration
    • Post-LH surge dosing of celecoxib

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Collaborator
    • Society of Family Planning
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alison Edelman, Assistant Professor SM.OB/GYN Generalist Division – Oregon Health and Science University
  • Overall Official(s)
    • Alison Edelman, MD, MPH, Principal Investigator, Oregon Health and Science University

Citations Reporting on Results

Edelman AB, Jensen JT, Doom C, Hennebold JD. Impact of the prostaglandin synthase-2 inhibitor celecoxib on ovulation and luteal events in women. Contraception. 2013 Mar;87(3):352-7. doi: 10.1016/j.contraception.2012.07.004. Epub 2012 Aug 16.

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