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

NCT ID: NCT00614406

Last Updated: 2012-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Ovulation (Follicular Rupture Yes/no) Menstrual Cycles (Total Length, Bleeding Days) Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)

Keywords

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Celebrex prostaglandin inhibitor ovulation menstrual cycles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Celebrex

Intervention Type DRUG

One 400mg tablet daily.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One tablet daily.

Interventions

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Celebrex

One 400mg tablet daily.

Intervention Type DRUG

Placebo

One tablet daily.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Alison Edelman

MD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison Edelman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Related Links

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http://www.ohsuwomenshealth.com/research/index.html

OHSU Women's Health Research Unit

Other Identifiers

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OHSU FAMPLAN 3854

Identifier Type: -

Identifier Source: org_study_id