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Trial record 1 of 1 for:    NCT00290251
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Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914

This study has been completed.
Sponsor:
Collaborator:
HRA Pharma
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00290251
First received: February 10, 2006
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
Results First Received: October 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Leiomyoma
Interventions: Drug: ulipristal acetate
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seventy-two women were screened for eligibility before being randomized to treatment 1. Of these only 42 were eligible to continue in the study.

Reporting Groups
  Description
Ulipristal Acetate - 20 mg Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
Ulipristal Acetate- 10 mg Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
Placebo (PLC) Women received placebo capsules for 90 - 102 days or three menstrual cycles.

Participant Flow for 3 periods

 Period 1:   Treatment 1 (Months 1 - 3)
    Ulipristal Acetate - 20 mg     Ulipristal Acetate- 10 mg     Placebo (PLC)  
STARTED     14     14     14  
COMPLETED     13     13     12  
NOT COMPLETED     1     1     2  
Withdrawal by Subject                 0                 0                 2  
headache                 0                 1                 0  
Out of body experience                 1                 0                 0  

Period 2:   Treatment 2 (Months 4 - 6)
    Ulipristal Acetate - 20 mg     Ulipristal Acetate- 10 mg     Placebo (PLC)  
STARTED     8 [1]   5 [2]   0 [3]
COMPLETED     6     5     0  
NOT COMPLETED     2     0     0  
Lost to Follow-up                 2                 0                 0  
[1] 2 crossed over from placebo; others in treatment 1 PLC or ulipristal acetate 20 did not continue
[2] 2 crossed over from placebo; others in treatment 1 PLC or ulipristal acetate 10 grp did not continue
[3] Women were randomized from PLC to ulipristal acetate or continued same dose ulipristal acetate

Period 3:   Elective Extension (to 12 Months no Rx)
    Ulipristal Acetate - 20 mg     Ulipristal Acetate- 10 mg     Placebo (PLC)  
STARTED     5 [1]   3 [1]   5 [1]
COMPLETED     5     3     5  
NOT COMPLETED     0     0     0  
[1] Extension study was elective and observational only; treatment arm given as last study drug group



  Baseline Characteristics
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Reporting Groups
  Description
Eligible Women All women who consented and were eligible

Baseline Measures
    Eligible Women  
Number of Participants  
[units: participants]
 		  42  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     42  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     42  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Shrinkage of Fibroids - Size of Fibroids   [ Time Frame: 3 months (baseline to end of treatment) ]
  Show Outcome Measure 1

2.  Secondary:   Quality of Life   [ Time Frame: 3 months (Baseline to end of treatment 1) ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Lynnette Nieman MD
Organization: NICHD, NIH
phone: 301-496-8935
e-mail: NiemanL@nih.gov


Publications:

Publications automatically indexed to this study:


Responsible Party: National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier: NCT00290251     History of Changes
Other Study ID Numbers: 060090, 1ZIAHD000637-17, 06-CH-0090
Study First Received: February 10, 2006
Results First Received: October 28, 2011
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration