NCT01129245

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ovulation
• Luteal Development

Interventions

Type	Name	Description
DRUG	Celebrex	400 mg PO daily intermittently based on hormone and ultrasound findings
DRUG	Placebo	Placebo identical to celecoxib

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-05-24
• Last updated: 2019-06-18
• Results posted: 2014-07-02

Locations

1 site across 1 country: United States