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

Study Overview
=================
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.

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

Conditions
-----------------
Ovulation, Luteal Development

Intervention / Treatment
-----------------
* Drug: Celebrex
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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 | One cycle corresponds to one participant | 4 cycles (approximately 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Hormone Levels | 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 | Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle. | 4 cycles (approximately 4 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celebrex, prostoglandin inhibitor, ovulation, emergency contraception