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

Overview[ - collapse ][ - ]

Purpose The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
ConditionOvulation (Follicular Rupture Yes/no)
Menstrual Cycles (Total Length, Bleeding Days)
Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
InterventionDrug: Celebrex
Drug: Placebo
PhaseN/A
SponsorOregon Health and Science University
Responsible PartyOregon Health and Science University
ClinicalTrials.gov IdentifierNCT00614406
First ReceivedJanuary 31, 2008
Last UpdatedDecember 11, 2012
Last verifiedDecember 2012

Tracking Information[ + expand ][ + ]

First Received DateJanuary 31, 2008
Last Updated DateDecember 11, 2012
Start DateJanuary 2008
Estimated Primary Completion DateAugust 2008
Current Primary Outcome MeasuresMenstrual Cycle Length [Time Frame: 3 months] [Designated as safety issue: No]Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleThe Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
Official TitleThe Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.
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.
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Condition
  • Ovulation (Follicular Rupture Yes/no)
  • Menstrual Cycles (Total Length, Bleeding Days)
  • Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
InterventionDrug: Celebrex
One 400mg tablet daily.
Drug: Placebo
One tablet daily.
Study Arm (s)
  • Experimental: 1
  • Placebo Comparator: 2

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment11
Estimated Completion DateAugust 2008
Estimated Primary Completion DateAugust 2008
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)
GenderFemale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00614406
Other Study ID NumbersOHSU FAMPLAN 3854
Has Data Monitoring CommitteeNo
Information Provided ByOregon Health and Science University
Study SponsorOregon Health and Science University
CollaboratorsSociety of Family Planning
Investigators Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
Verification DateDecember 2012

Locations[ + expand ][ + ]

Oregon Health & Science University
Portland, Oregon, United States, 97239