N/A
Completed N=20
The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Ovulation · Luteal Development
Source: ClinicalTrials.gov NCT01129245 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase — 1; 6; 5 Participants
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.
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 | — |
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
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. Informational only — not medical advice.