Skip to main content
OpenTrials
Completed

NCT Number: NCT00614406

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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 sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Celebrex

Drug

One 400mg tablet daily.

Placebo

Drug

One tablet daily.

Primary outcomes

  1. Menstrual Cycle Length

    Time frame: 3 months

    Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2008
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.