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Trial record 68 of 543 for:    Celecoxib

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Conditions Ovulation
Luteal Development
Interventions Drug: Celebrex
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PreLH Followed by postLH PostLH Followed by preLH
Hide Arm/Group Description Control cycle First, preLH surge dosing of celecoxib and postLH surge dosing of placebo. Followed by, preLH surge dosing of placebo and postLH surge dosing of drug. Control cycle First, postLH surge dosing of celecoxib and preLH surge dosing of placebo. Followed by, postLH surge dosing of placebo and preLH surge dosing of drug.
Period Title: Control Cycle (no Celecoxib or Placebo)
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Treatment Cycle 1
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Washout Cycle
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Treatment Cycle 2
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title PreLH/postLH PostLH/preLH Total
Hide Arm/Group Description Control cycle First, preLH surge dosing of celecoxib and postLH surge dosing of placebo. Followed by, preLH surge dosing of placebo and postLH surge dosing of drug. Control cycle First, postLH surge dosing of celecoxib and preLH surge dosing of placebo. Followed by, postLH surge dosing of placebo and preLH surge dosing of drug. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
healthy reproductive-aged women with regular cycles, not currently using or needing hormonal contraception
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
26.2  (5.9) 28.5  (4.9) 27.4  (5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
10
 100.0%
10
 100.0%
20
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Non-Hispanic, Caucasian
9
  90.0%
8
  80.0%
17
  85.0%
Other
1
  10.0%
2
  20.0%
3
  15.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase
Hide Description One cycle corresponds to one participant
Time Frame 4 cycles (approximately 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.
Arm/Group Title Control Cycle Pre-LH Celecoxib Post-LH Surge Celecoxib
Hide Arm/Group Description:
Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.

Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results

Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings

Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.

Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings

Overall Number of Participants Analyzed 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
6
  30.0%
5
  25.0%
2.Secondary Outcome
Title Peak Hormone Levels
Hide Description Average serum levels of progesterone (ng/mL) and luteinizing hormone (ng/mL) normalized to days of the luteal phase of menstrual cycle.
Time Frame 4 cycles (approximately 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
One cycle corresponds to one participant. Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.
Arm/Group Title Control Cycle Pre-LH Celecoxib Post-LH Surge Celecoxib
Hide Arm/Group Description:
Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.
Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings

Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.

Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings

Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
LH (luteinizing hormone) 39.7  (25) 46.2  (28.4) 42.6  (22.2)
P (progesterone) 13.3  (3.3) 13.5  (3.9) 12.3  (4.7)
3.Secondary Outcome
Title Peak Estradiol Level
Hide Description Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.
Time Frame 4 cycles (approximately 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
One cycle corresponds to one participant. Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.
Arm/Group Title Control Cycle Pre-LH Celecoxib Post-LH Surge Celecoxib
Hide Arm/Group Description:
Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.
Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings

Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.

Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings

Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: pg/mL
274  (99.6) 289.4  (124.5) 282.2  (106.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Cycle Pre-LH Celecoxib Post-LH Surge Celecoxib
Hide Arm/Group Description Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.

Received Celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.

Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings.

Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.

Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings

All-Cause Mortality
Control Cycle Pre-LH Celecoxib Post-LH Surge Celecoxib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Cycle Pre-LH Celecoxib Post-LH Surge Celecoxib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Cycle Pre-LH Celecoxib Post-LH Surge Celecoxib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alison Edelman
Organization: Oregon Health and Science University
Phone: 503-494-5949
EMail: edelmana@ohsu.edu
Layout table for additonal information
Responsible Party: Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01129245     History of Changes
Other Study ID Numbers: OHSU FAMPLAN SFP3-7
First Submitted: May 21, 2010
First Posted: May 24, 2010
Results First Submitted: April 7, 2014
Results First Posted: July 2, 2014
Last Update Posted: June 18, 2019