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Trial record 71 of 549 for:    Celecoxib

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

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ClinicalTrials.gov Identifier: NCT01129245
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : July 2, 2014
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Ovulation Luteal Development Drug: Celebrex Drug: Placebo Not Applicable

Detailed Description:

A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2). Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the above treatment schemes and received the other in the subsequent treatment cycle.

This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib, would be a more effective agent in terms of causing ovulatory dysfunction. This study also aims to determine whether treatment with celecoxib would adversely affect luteal function.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
No Intervention: Control cycle
Control menstrual cycle
Experimental: Pre-LH surge celecoxib administration
Pre-LH surge dosing of celecoxib
Drug: Celebrex
400 mg PO daily intermittently based on hormone and ultrasound findings
Other Name: Celecoxib

Drug: Placebo
Placebo identical to celecoxib

Experimental: Post-LH surge celecoxib administration
Post-LH surge dosing of celecoxib
Drug: Celebrex
400 mg PO daily intermittently based on hormone and ultrasound findings
Other Name: Celecoxib

Drug: Placebo
Placebo identical to celecoxib




Primary Outcome Measures :
  1. Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase [ Time Frame: 4 cycles (approximately 4 months) ]
    One cycle corresponds to one participant


Secondary Outcome Measures :
  1. Peak Hormone Levels [ Time Frame: 4 cycles (approximately 4 months) ]
    Average serum levels of progesterone (ng/mL) and luteinizing hormone (ng/mL) normalized to days of the luteal phase of menstrual cycle.

  2. Peak Estradiol Level [ Time Frame: 4 cycles (approximately 4 months) ]
    Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129245


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
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Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University

Additional Information:
Publications of Results:
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Responsible Party: Alison Edelman, Assistant Professor SM.OB/GYN Generalist Division, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01129245     History of Changes
Other Study ID Numbers: OHSU FAMPLAN SFP3-7
First Posted: May 24, 2010    Key Record Dates
Results First Posted: July 2, 2014
Last Update Posted: June 18, 2019
Last Verified: May 2019
Keywords provided by Alison Edelman, Oregon Health and Science University:
Celebrex
prostoglandin inhibitor
ovulation
emergency contraception
Additional relevant MeSH terms:
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Celecoxib
Cyclooxygenase 2 Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action