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.
ConditionOvulation
Luteal Development
InterventionDrug: celebrex
PhaseN/A
SponsorOregon Health and Science University
Responsible PartyOregon Health and Science University
ClinicalTrials.gov IdentifierNCT01129245
First ReceivedMay 21, 2010
Last UpdatedDecember 10, 2012
Last verifiedDecember 2012

Tracking Information[ + expand ][ + ]

First Received DateMay 21, 2010
Last Updated DateDecember 10, 2012
Start DateSeptember 2009
Estimated Primary Completion DateSeptember 2011
Current Primary Outcome MeasuresWhen 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 MeasuresWhen 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 TitleThe Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Official TitleThe 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 DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Condition
  • Ovulation
  • Luteal Development
InterventionDrug: 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 StatusCompleted
Estimated Enrollment20
Estimated Completion DateSeptember 2011
Estimated Primary Completion DateSeptember 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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01129245
Other Study ID NumbersOHSU FAMPLAN SFP3-7
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