N/A
Completed 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)
Source: ClinicalTrials.gov NCT00614406 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: Menstrual Cycle Length — 28.5; 27.2 Days
Summary
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Menstrual Cycle Length |
28.5; 27.2 | — |
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. Informational only — not medical advice.