Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P), Menstrual Cycles (Total Length, Bleeding Days), Ovulation (Follicular Rupture Yes/no)
Conditions
Keywords
Celebrex, prostaglandin inhibitor, ovulation, menstrual cycles
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 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.
Interventions
DRUGCelebrex
One 400mg tablet daily.
DRUGPlacebo
One tablet daily.
Sponsors
Society of Family Planning
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual Cycle Length | 3 months | Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry. |
Countries
United States
Participant flow
Recruitment details
Potential subjects may also have learned about the study from an OHSU Center for Women's Health provider.Visit 1: reviewed of medical history and demographics and vital signs. A blood draw and urine pregnancy test was performed. Eligible subjects returned for the enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Active Drug Cycle Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle | 7 |
| Placebo Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle | 4 |
| Total | 11 |
Baseline characteristics
| Characteristic | Active Drug Cycle | Placebo | Total |
|---|---|---|---|
| Age Continuous | 27.3 years STANDARD_DEVIATION 5.2 | 28.8 years STANDARD_DEVIATION 6.1 | 27.85 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 7 participants | 4 participants | 11 participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Menstrual Cycle Length
Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.
Time frame: 3 months
Population: Intention to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Drug | Menstrual Cycle Length | 28.5 Days | Standard Deviation 2.5 |
| Placebo | Menstrual Cycle Length | 27.2 Days | Standard Deviation 2.4 |