N/A N=20 Randomized Double-blind Diagnostic

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

Ovulation · Luteal Development

Bottom Line

View on ClinicalTrials.gov: NCT01129245 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase — 1; 6; 5 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Celebrex (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase	1; 6; 5	—
SECONDARY Peak Hormone Levels	39.7; 46.2; 42.6; 13.3; 13.5; 12.3	—
SECONDARY Peak Estradiol Level	274; 289.4; 282.2	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01129245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.