The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Ovulation Luteal Development |
Intervention | Drug: celebrex |
Phase | N/A |
Sponsor | Oregon Health and Science University |
Responsible Party | Oregon Health and Science University |
ClinicalTrials.gov Identifier | NCT01129245 |
First Received | May 21, 2010 |
Last Updated | December 10, 2012 |
Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | May 21, 2010 |
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Last Updated Date | December 10, 2012 |
Start Date | September 2009 |
Estimated Primary Completion Date | September 2011 |
Current Primary Outcome Measures | When taken before ovulation: blocking ovulation When taken after ovulation: extended luteal phase [Time Frame: Completion of study (1 year)] [Designated as safety issue: No] |
Current Secondary Outcome Measures | When taken before ovulation: delaying ovulation When taken after ovulation: premature onset of menses [Time Frame: completion of study (1 year)] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation |
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Official Title | The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation |
Brief 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic |
Condition |
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Intervention | Drug: celebrex 400 mg PO daily intermittently based on hormone and ultrasound findings Other Names: celecoxib |
Study Arm (s) | Experimental: Celebrex receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 20 |
Estimated Completion Date | September 2011 |
Estimated Primary Completion Date | September 2011 |
Eligibility 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 |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01129245 |
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Other Study ID Numbers | OHSU FAMPLAN SFP3-7 |
Has Data Monitoring Committee | No |
Information Provided By | Oregon Health and Science University |
Study Sponsor | Oregon Health and Science University |
Collaborators | Society of Family Planning |
Investigators | Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University |
Verification Date | December 2012 |
Locations[ + expand ][ + ]
Oregon Health & Science University | Portland, Oregon, United States, 97239 |
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