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Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Mayo Clinic
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01376349
First received: June 17, 2011
Last updated: July 25, 2017
Last verified: July 2017
Results First Received: December 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions: Breast Cancer
Gynecologic Cancer
Interventions: Drug: prasterone
Other: 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
A total of 464 patients were accrued to this trial. Nineteen patients withdrew consent prior to randomization and were not included in the analysis of this study. Two additional patients were unable to classify the primary symptom and were not randomized to the trial and were not included in the analysis.

Reporting Groups
  Description
Arm I Low Dose DHEA Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Arm II High Dose DHEA Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Arm III Placebo

Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.

There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.


Participant Flow for 2 periods

Period 1:   Raondomized Treatment
    Arm I Low Dose DHEA   Arm II High Dose DHEA   Arm III Placebo
STARTED   147   149   147 
COMPLETED   123   114   118 
NOT COMPLETED   24   35   29 
Withdrawal by Subject                10                16                13 
Adverse Event                13                17                14 
Unkown                1                2                1 
Alternative Treatment                0                0                1 

Period 2:   Optional Continuation Phase
    Arm I Low Dose DHEA   Arm II High Dose DHEA   Arm III Placebo
STARTED   0   0   94 [1] 
COMPLETED   0   0   94 
NOT COMPLETED   0   0   0 
[1] Patients completing Arm III Placebo were offered the option of continuing High Dose DHEA



  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.
All patients that were randomized to treatment were included in baseline characteristics.

Reporting Groups
  Description
Arm I Low Dose DHEA Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Arm II High Dose DHEA Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Arm III Placebo

Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks. >

> There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.

Total Total of all reporting groups

Baseline Measures
   Arm I Low Dose DHEA   Arm II High Dose DHEA   Arm III Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 147   149   147   443 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.8  (6.7)   57.3  (8.2)   58  (7.3)   57.3  (7.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      147 100.0%      149 100.0%      147 100.0%      443 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   147   149   147   443 


  Outcome Measures

1.  Primary:   Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks   [ Time Frame: At baseline and 12 weeks ]


  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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Debra Barton, R.N., Ph.D.
Organization: Alliance for Clinical Trials in Oncology
e-mail: debbartn@med.umich.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01376349     History of Changes
Other Study ID Numbers: NCCTG-N10C1
CDR0000702003 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-02677 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Study First Received: June 17, 2011
Results First Received: December 8, 2016
Last Updated: July 25, 2017