Status:

COMPLETED

The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle

Lead Sponsor:

Oregon Health and Science University

Collaborating Sponsors:

Society of Family Planning

Conditions:

Ovulation (Follicular Rupture Yes/no)

Menstrual Cycles (Total Length, Bleeding Days)

Eligibility:

FEMALE

18-35 years

Phase:

NA

Brief Summary

The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.

Detailed Description

Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected se...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2008

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT00614406

Start Date

January 1 2008

End Date

August 1 2008

Last Update

December 13 2012

Active Locations (1)

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1

Oregon Health & Science University

Portland, Oregon, United States, 97239