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

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Luteal Development; Ovulation

Treatments: Drug: Celebrex; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01129245

OHSU FAMPLAN SFP3-7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups

Control cycle

No Intervention group

Description:

Control menstrual cycle

Pre-LH surge celecoxib administration

Experimental group

Description:

Pre-LH surge dosing of celecoxib

Treatment:

Drug: Placebo

Drug: Celebrex

Post-LH surge celecoxib administration

Experimental group

Description:

Post-LH surge dosing of celecoxib

Treatment:

Drug: Placebo

Drug: Celebrex