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

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: NCT01376349
Recruitment Status : Completed
First Posted : June 20, 2011
Results First Posted : August 25, 2017
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Mayo Clinic
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

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
Enrollment 464
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Arm I Low Dose DHEA Arm II High Dose DHEA Arm III Placebo
Hide Arm/Group Description 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. 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.

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.

Period Title: Raondomized Treatment
Started 147 149 147
Completed 123 114 118
Not Completed 24 35 29
Reason Not Completed
Withdrawal by Subject             10             16             13
Adverse Event             13             17             14
Unkown             1             2             1
Alternative Treatment             0             0             1
Period Title: Optional Continuation Phase
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
Arm/Group Title Arm I Low Dose DHEA Arm II High Dose DHEA Arm III Placebo Total
Hide Arm/Group Description 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. 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.

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 of all reporting groups
Overall Number of Baseline Participants 147 149 147 443
Hide Baseline Analysis Population Description
All patients that were randomized to treatment were included in baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 149 participants 147 participants 443 participants
56.8  (6.7) 57.3  (8.2) 58  (7.3) 57.3  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 149 participants 147 participants 443 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 147 participants 149 participants 147 participants 443 participants
147 149 147 443
1.Primary Outcome
Title Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks
Hide Description The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).
Time Frame At baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that started treatment and completed their week 12 evaluation are included in this analysis.
Arm/Group Title Arm I Low Dose DHEA Arm II High Dose DHEA Arm III Placebo
Hide Arm/Group Description:
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.
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.

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.

Overall Number of Participants Analyzed 123 114 118
Median (Full Range)
Unit of Measure: change in units on a scale
-2
(-4 to 1)
-2
(-4 to 1)
-1
(-4 to 1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II High Dose DHEA, Arm III Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I Low Dose DHEA, Arm III Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.
 
Arm/Group Title Arm I: Low Dose DHEA Arm II: High Dose DHEA Arm III: Placebo Optional Continuation Phase
Hide Arm/Group Description 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. 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.

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.

Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study.

94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA.

All-Cause Mortality
Arm I: Low Dose DHEA Arm II: High Dose DHEA Arm III: Placebo Optional Continuation Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I: Low Dose DHEA Arm II: High Dose DHEA Arm III: Placebo Optional Continuation Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/147 (2.04%)      7/148 (4.73%)      4/147 (2.72%)      0/94 (0.00%)    
Infections and infestations         
Bladder infection  1  1/147 (0.68%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
Breast infection  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Urinary tract infection  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Vaginal infection  1  1/147 (0.68%)  1 1/148 (0.68%)  1 1/147 (0.68%)  1 0/94 (0.00%)  0
Investigations         
Investigations - Other, specify  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Nervous system disorders         
Headache  1  1/147 (0.68%)  1 1/148 (0.68%)  2 1/147 (0.68%)  1 0/94 (0.00%)  0
Reproductive system and breast disorders         
Breast pain  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Voice alteration  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Skin and subcutaneous tissue disorders         
Hirsutism  1  0/147 (0.00%)  0 2/148 (1.35%)  3 0/147 (0.00%)  0 0/94 (0.00%)  0
Rash acneiform  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I: Low Dose DHEA Arm II: High Dose DHEA Arm III: Placebo Optional Continuation Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/147 (61.90%)      105/148 (70.95%)      93/147 (63.27%)      28/94 (29.79%)    
Blood and lymphatic system disorders         
Anemia  1  1/147 (0.68%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
Cardiac disorders         
Atrial fibrillation  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Cardiac disorders - Other, specify  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  6 0/94 (0.00%)  0
Ear and labyrinth disorders         
Ear pain  1  1/147 (0.68%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Small intestinal obstruction  1  1/147 (0.68%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
Small intestine ulcer  1  1/147 (0.68%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
General disorders         
Fatigue  1  1/147 (0.68%)  2 1/148 (0.68%)  2 1/147 (0.68%)  1 0/94 (0.00%)  0
Fever  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Flu like symptoms  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Irritability  1  1/147 (0.68%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
Non-cardiac chest pain  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Pain  1  0/147 (0.00%)  0 0/148 (0.00%)  0 0/147 (0.00%)  0 1/94 (1.06%)  1
Immune system disorders         
Allergic reaction  1  5/147 (3.40%)  6 3/148 (2.03%)  3 2/147 (1.36%)  5 0/94 (0.00%)  0
Infections and infestations         
Bladder infection  1  1/147 (0.68%)  1 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Breast infection  1  1/147 (0.68%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
Infections and infestations - Other, specify  1  1/147 (0.68%)  2 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
Upper respiratory infection  1  0/147 (0.00%)  0 1/148 (0.68%)  1 1/147 (0.68%)  1 0/94 (0.00%)  0
Urethral infection  1  1/147 (0.68%)  1 0/148 (0.00%)  0 0/147 (0.00%)  0 0/94 (0.00%)  0
Urinary tract infection  1  6/147 (4.08%)  9 3/148 (2.03%)  3 5/147 (3.40%)  5 0/94 (0.00%)  0
Vaginal infection  1  3/147 (2.04%)  6 5/148 (3.38%)  6 2/147 (1.36%)  3 1/94 (1.06%)  1
Injury, poisoning and procedural complications         
Wound complication  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  2 0/94 (0.00%)  0
Metabolism and nutrition disorders         
Hypercalcemia  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Hypertriglyceridemia  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Joint effusion  1  1/147 (0.68%)  1 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1  1/147 (0.68%)  1 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/147 (0.00%)  0 0/148 (0.00%)  0 0/147 (0.00%)  0 1/94 (1.06%)  1
Nervous system disorders         
Headache  1  54/147 (36.73%)  130 55/148 (37.16%)  112 51/147 (34.69%)  145 12/94 (12.77%)  18
Psychiatric disorders         
Agitation  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Anorgasmia  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Insomnia  1  0/147 (0.00%)  0 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Renal and urinary disorders         
Bladder spasm  1  0/147 (0.00%)  0 0/148 (0.00%)  0 0/147 (0.00%)  0 1/94 (1.06%)  1
Urinary tract pain  1  0/147 (0.00%)  0 3/148 (2.03%)  3 0/147 (0.00%)  0 0/94 (0.00%)  0
Reproductive system and breast disorders         
Breast pain  1  29/147 (19.73%)  78 39/148 (26.35%)  96 33/147 (22.45%)  94 7/94 (7.45%)  14
Dyspareunia  1  2/147 (1.36%)  7 1/148 (0.68%)  1 1/147 (0.68%)  1 0/94 (0.00%)  0
Reproductive system and breast disorders - Other, specify  1  1/147 (0.68%)  1 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Vaginal discharge  1  6/147 (4.08%)  13 7/148 (4.73%)  9 5/147 (3.40%)  6 2/94 (2.13%)  3
Vaginal dryness  1  9/147 (6.12%)  33 4/148 (2.70%)  4 1/147 (0.68%)  1 0/94 (0.00%)  0
Vaginal inflammation  1  0/147 (0.00%)  0 2/148 (1.35%)  2 2/147 (1.36%)  2 1/94 (1.06%)  1
Vaginal pain  1  2/147 (1.36%)  2 2/148 (1.35%)  2 1/147 (0.68%)  2 1/94 (1.06%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnea  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Voice alteration  1  8/147 (5.44%)  18 16/148 (10.81%)  32 15/147 (10.20%)  29 2/94 (2.13%)  2
Skin and subcutaneous tissue disorders         
Hirsutism  1  15/147 (10.20%)  50 26/148 (17.57%)  86 20/147 (13.61%)  50 6/94 (6.38%)  11
Hyperhidrosis  1  0/147 (0.00%)  0 1/148 (0.68%)  3 0/147 (0.00%)  0 0/94 (0.00%)  0
Hypertrichosis  1  2/147 (1.36%)  2 10/148 (6.76%)  26 7/147 (4.76%)  13 0/94 (0.00%)  0
Pain of skin  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Pruritus  1  0/147 (0.00%)  0 2/148 (1.35%)  2 1/147 (0.68%)  1 0/94 (0.00%)  0
Rash acneiform  1  12/147 (8.16%)  20 33/148 (22.30%)  56 27/147 (18.37%)  58 2/94 (2.13%)  2
Rash maculo-papular  1  8/147 (5.44%)  16 11/148 (7.43%)  14 12/147 (8.16%)  24 2/94 (2.13%)  3
Skin and subcutaneous tissue disorders - Other, specify  1  0/147 (0.00%)  0 1/148 (0.68%)  1 0/147 (0.00%)  0 0/94 (0.00%)  0
Vascular disorders         
Hot flashes  1  1/147 (0.68%)  1 3/148 (2.03%)  4 0/147 (0.00%)  0 0/94 (0.00%)  0
Hypertension  1  1/147 (0.68%)  1 0/148 (0.00%)  0 1/147 (0.68%)  1 0/94 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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.
Results Point of Contact
Name/Title: Debra Barton, R.N., Ph.D.
Organization: Alliance for Clinical Trials in Oncology
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01376349     History of Changes
Other Study ID Numbers: NCCTG-N10C1
NCCTG-N10C1
CDR0000702003 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-02677 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: June 17, 2011
First Posted: June 20, 2011
Results First Submitted: December 8, 2016
Results First Posted: August 25, 2017
Last Update Posted: February 7, 2019