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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Celebrex

Placebo

About this trial

This is an interventional diagnostic trial for Ovulation (Follicular Rupture Yes/no) focused on measuring Celebrex, prostaglandin inhibitor, ovulation, menstrual cycles

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts 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)

Sites / Locations

Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Menstrual Cycle Length

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00614406

First Posted

January 31, 2008

Last Updated

December 11, 2012

Sponsor

Oregon Health and Science University

Collaborators

Society of Family Planning

1. Study Identification

Unique Protocol Identification Number

NCT00614406

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

Collaborators

Society of Family Planning

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Celebrex, prostaglandin inhibitor, ovulation, menstrual cycles

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Celebrex

Intervention Description

One 400mg tablet daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One tablet daily.

Primary Outcome Measure Information:

Title

Menstrual Cycle Length

Description

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

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison Edelman, MD, MPH

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Links:

URL

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

Description

OHSU Women's Health Research Unit

Learn more about this trial

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

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