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Completed

NCT Number: NCT01129245

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

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.

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Key information

Conditions

Ovulation Luteal Development

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celebrex

Drug

400 mg PO daily intermittently based on hormone and ultrasound findings

Other names: Celecoxib

Placebo

Drug

Placebo identical to celecoxib

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Society of Family Planning

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 24, 2010
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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