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

Not Applicable

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Post-LH surge celecoxib administration	Placebo	Post-LH surge dosing of celecoxib
Pre-LH surge celecoxib administration	Placebo	Pre-LH surge dosing of celecoxib
Pre-LH surge celecoxib administration	Celebrex	Pre-LH surge dosing of celecoxib
Post-LH surge celecoxib administration	Celebrex	Post-LH surge dosing of celecoxib

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Peak Estradiol Level	4 cycles (approximately 4 months)	Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.
Peak Hormone Levels	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.