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

Oregon Health & Science University (OHSU)

Status

Completed

Conditions

Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)

Ovulation (Follicular Rupture Yes/no)

Menstrual Cycles (Total Length, Bleeding Days)

Treatments

Drug: Celebrex

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00614406

OHSU FAMPLAN 3854

Details and patient eligibility

About

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

Full 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 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.

Enrollment

11 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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)