Clinical trial NCT01129245: The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Official title: The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovulation
Luteal Development
Keywords: Celebrex
prostoglandin inhibitor
ovulation
emergency contraception
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2010-05-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase
timeFrame: 4 cycles (approximately 4 months)
Secondary outcomes:
measure: Peak Hormone Levels
timeFrame: 4 cycles (approximately 4 months)
measure: Peak Estradiol Level
timeFrame: 4 cycles (approximately 4 months)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alison Edelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edelman AB, Jensen JT, Doom C, Hennebold JD. Impact of the prostaglandin synthase-2 inhibitor celecoxib on ovulation and luteal events in women. Contraception. 2013 Mar;87(3):352-7. doi: 10.1016/j.contraception.2012.07.004. Epub 2012 Aug 16.