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The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation

Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovulation; Luteal Development

Intervention: celebrex (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Oregon Health and Science University

Official(s) and/or principal investigator(s):
Alison Edelman, MD, MPH, Principal Investigator, Affiliation: Oregon Health and Science University

Summary

The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.

Clinical Details

Official title: The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Primary outcome: Menstrual Length When Taken After Ovulation: Extended Luteal Phase

Secondary outcome: Change in Luteal Phase Progesterone Levels

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Age 18-35

- Currently NOT using hormonal contraception

- Cycle length between 26-34 days

- General good health (specifically no hx of: diabetes, cardiac problems,

moderate/severe heart burn (GERD), obesity (BMI > 30), hypertension (BP > 130/80)

- Willing and able to agree to randomization and informed consent

- Willing and able to use a menstrual diary to chart bleeding Serum progesterone > 3

ng/ml (from cycle day 18-25)

- Willing and able to return to clinic for bi-weekly for blood tests and ultrasounds

throughout cycles 2, 3 & 5 Exclusion Criteria:

- Diabetes

- Cardiac disease

- Moderate to severe heart burn (or GERD) Obesity (BMI > 30) Hypertension (BP > 130/80)

- Allergy to NSAIDS

- Currently pregnant or trying to conceive

- Polycystic Ovarian Syndrome

- Use of hormonal contraception (participants can use barrier methods, spermicide,

female or male sterilization, copper intrauterine device, abstinence, or have female partners

Locations and Contacts

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

Starting date: September 2009
Last updated: July 2, 2014

Page last updated: August 20, 2015

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