N/A
N=11
The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
Ovulation (Follicular Rupture Yes/no) · Menstrual Cycles (Total Length, Bleeding Days) · Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
Bottom Line
View on ClinicalTrials.gov: NCT00614406 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Menstrual Cycle Length — 28.5; 27.2 Days
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
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Menstrual Cycle Length |
28.5; 27.2 | — |
Summary
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
Eligibility Criteria
Inclusion Criteria
- Age 18-35
- Normal menstrual periods (24-35 days)
- Good general health
- Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence)
- Willing and able to return to clinic for bi-weekly blood tests
Exclusion Criteria
- Pregnant or breast feeding
- Polycystic ovarian disease
- Gastrointestinal conditions (i.e.gastric ulcer)
- Currently using birth control
- Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs
- Diabetes
- Cardiac disease or hypertension
- Moderate to severe heartburn (GERD)
- Obesity (BMI greater than 30)
Data sourced from ClinicalTrials.gov (NCT00614406). 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.