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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ovulation Luteal Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control cycle

Control menstrual cycle

Group Type NO_INTERVENTION

No interventions assigned to this group

Pre-LH surge celecoxib administration

Pre-LH surge dosing of celecoxib

Group Type EXPERIMENTAL

Celebrex

Intervention Type DRUG

400 mg PO daily intermittently based on hormone and ultrasound findings

Placebo

Intervention Type DRUG

Placebo identical to celecoxib

Post-LH surge celecoxib administration

Post-LH surge dosing of celecoxib

Group Type EXPERIMENTAL

Celebrex

Intervention Type DRUG

400 mg PO daily intermittently based on hormone and ultrasound findings

Placebo

Intervention Type DRUG

Placebo identical to celecoxib

Interventions

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Celebrex

400 mg PO daily intermittently based on hormone and ultrasound findings

Intervention Type DRUG

Placebo

Placebo identical to celecoxib

Intervention Type DRUG

Other Intervention Names

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Celecoxib

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes