The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Amy DiVasta, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00474851
First received: May 15, 2007
Last updated: March 17, 2015
Last verified: March 2015
Results First Received: March 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Endometriosis
Interventions: Drug: Norethindrone acetate + estrogens
Drug: norethindrone acetate + 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
No text entered.

Reporting Groups
  Description
Intervention Group

Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily

Norethindrone acetate: Norethindrone acetate 5 mg PO daily

Placebo Group

Placebo group

Placebo: Placebo capsule 1 pill PO daily

Norethindrone acetate: Norethindrone acetate 5 mg PO daily


Participant Flow:   Overall Study
    Intervention Group     Placebo Group  
STARTED     26     27  
Completed Baseline     25     26  
COMPLETED     18     16  
NOT COMPLETED     8     11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Group

Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily

Norethindrone acetate: Norethindrone acetate 5 mg PO daily

Placebo Group

Placebo: Placebo capsule 1 pill PO daily

Norethindrone acetate: Norethindrone acetate 5 mg PO daily

Total Total of all reporting groups

Baseline Measures
    Intervention Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  25     26     51  
Age  
[units: years]
Mean (Standard Deviation)
  17.7  (1.4)     18.1  (1.9)     17.9  (1.7)  
Gender  
[units: participants]
     
Female     25     26     51  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     25     26     51  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White     23     26     49  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     25     26     51  



  Outcome Measures
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1.  Primary:   Bone Mineral Density   [ Time Frame: Baseline to 12 months ]

2.  Secondary:   Total Body Bone Mineral Content (BMC)   [ Time Frame: Baseline to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Sample of skeletally mature young women; Measurements of aBMD are two-dimensional and do not yield information regarding skeletal strength or microarchitecture


  More Information
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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:  
Name/Title: Dr. Amy D. DiVasta
Organization: Boston Children's Hospital
phone: 617-355-3792
e-mail: Amy.DiVasta@childrens.harvard.edu


No publications provided


Responsible Party: Amy DiVasta, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00474851     History of Changes
Other Study ID Numbers: 07-01-0004
Study First Received: May 15, 2007
Results First Received: March 4, 2015
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration