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Trial record 29 of 2075 for:    ESTRADIOL

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients (E-String)

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ClinicalTrials.gov Identifier: NCT00698035
Recruitment Status : Completed
First Posted : June 16, 2008
Results First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Sexual Dysfunction, Physiological
Interventions Drug: Testosterone Cream
Drug: Estring
Enrollment 76
Recruitment Details  
Pre-assignment Details Of 76 enrolled participants, one participant consented and was assigned to ESTRING, but did not insert ESTRING prior to withdrawing from the study.
Arm/Group Title Estring Testosterone Cream
Hide Arm/Group Description Estring 2mg ring inserted vaginally once every 12 weeks Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
Period Title: Overall Study
Started 39 36
Completed 35 34
Not Completed 4 2
Arm/Group Title Estring Testosterone Cream Total
Hide Arm/Group Description Estring 2mg ring inserted vaginally once every 12 weeks Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment Total of all reporting groups
Overall Number of Baseline Participants 39 36 75
Hide Baseline Analysis Population Description
Baseline Characteristics for 75 participants who initiated treatment. One participant consented and was assigned to ESTRING, but did not insert ESTRING prior to withdrawing from the study.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants 36 participants 75 participants
56
(37 to 78)
57
(38 to 74)
56
(37 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 36 participants 75 participants
Female
39
 100.0%
36
 100.0%
75
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 36 participants 75 participants
39 36 75
1.Primary Outcome
Title Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range
Hide Description Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, to be considered evaluable for the Primary Outcome, patients must complete both baseline evaluation and week 4 safety blood draw. 1 participant in the Testosterone arm was not evaluable.
Arm/Group Title Estring Testosterone Cream
Hide Arm/Group Description:
Estring 2mg ring inserted vaginally once every 12 weeks
Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
Overall Number of Participants Analyzed 35 33
Measure Type: Number
Unit of Measure: participants
0 4
2.Secondary Outcome
Title Serum Estradiol (E2)
Hide Description serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, participants who completed 12 weeks of assigned treatment
Arm/Group Title Estring Testosterone Cream
Hide Arm/Group Description:
Estring 2mg ring inserted vaginally once every 12 weeks
Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
Overall Number of Participants Analyzed 35 34
Mean (Standard Deviation)
Unit of Measure: pg/ml
E2 at baseline 27  (36) 9  (13)
E2 at 4 weeks 5  (5) 10  (20)
E2 at 12 weeks 9  (12) 8  (7)
3.Secondary Outcome
Title Matched E2 by Commercial and Research (RIA) Analyses
Hide Description Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women
Time Frame baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients from both study arms arms with matched pairs of baseline and week 4 E2 performed by both commercial and research labs
Arm/Group Title E2 by LC/MS E2 by RIA
Hide Arm/Group Description:
A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range <10 pg/ml)
Additional measurement of baseline and week 4 E2 by RIA
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: pg/ml
Baseline E2 17.7  (28.5) 17.9  (44.1)
4-week E2 7.8  (15.0) 2.9  (13.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E2 by LC/MS, E2 by RIA
Comments Comparison of baseline estradiol between LC/MS and RIA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection E2 by LC/MS, E2 by RIA
Comments Comparison of week 4 estradiol between LC/MS and RIA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments singificant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Total Testosterone Levels
Hide Description By serum ultrasensitive total testosterone test (Quest Diagnostics)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, participants assigned to the Testosterone arm who completed 12 weeks of assigned treatment and had testosterone measurement at baseline, 4 weeks and 12 weeks.
Arm/Group Title Testosterone Cream
Hide Arm/Group Description:
Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: ng/dl
Testosterone at baseline 33  (19)
Testosterone at 4 weeks 186  (276)
Testosterone at 12 weeks 171  (251)
5.Secondary Outcome
Title Sexual Quality of Life
Hide Description Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.
Time Frame Baseline, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided responses to SD, SI and SS at 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)
Arm/Group Title Estring Testosterone Cream
Hide Arm/Group Description:
Estring 2mg ring inserted vaginally once every 12 weeks
Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
SI (BL) 1.2  (0.9) 1.4  (0.8)
SI (W4) 1.3  (1.0) 1.2  (0.7)
SI (W12) 0.9  (0.7) 1.0  (0.6)
SD (BL) 2.9  (1.1) 2.9  (0.8)
SD (W4) 2.4  (1.1) 2.1  (1.0)
SD (W12) 2.0  (1.1) 1.9  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Estring
Comments Change in SI from BL to W12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Estring
Comments Change in SD from BL to W12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Testosterone Cream
Comments Change in SI from BL to W12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0228
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Testosterone Cream
Comments Change in SD from BL to W12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Sexual Satisfaction
Hide Description Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked "Overall, how satisfactory to you is your sexual relationship with your partner?" Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory).
Time Frame Baseline, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided responses to SD, SI and SS at all 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)
Arm/Group Title Estring Testosterone Cream
Hide Arm/Group Description:
Estring 2mg ring inserted vaginally once every 12 weeks
Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
SS (BL) 2.5  (1.6) 3.2  (1.6)
SS (W4) 3.5  (1.8) 3.7  (1.6)
SS (W12) 4.0  (1.5) 4.0  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Estring
Comments Change in SS from Baseline to Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Testosterone Cream
Comments Change in SS from Baseline to Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change in Vaginal Epithelium Scores
Hide Description During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with both baseline and week 12 gynecologic exams for evaluation of vaginal atrophy
Arm/Group Title Estring Testosterone Cream
Hide Arm/Group Description:
Estring 2mg ring inserted vaginally once every 12 weeks
Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
Overall Number of Participants Analyzed 35 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
Rugae -1.03  (0.80) -0.71  (0.84)
Pallor -0.88  (0.84) -0.91  (0.75)
Petechiae -1.0  (1.07) -0.74  (1.38)
Mucosal thinning -0.62  (0.49) -0.88  (0.64)
Dryness -1.03  (0.80) -0.71  (0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Estring
Comments Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Testosterone Cream
Comments Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Testosterone Cream
Comments Difference in petechiae between baseline and week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments Significant at p<0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Estring Testosterone Cream
Hide Arm/Group Description Estring 2mg ring inserted vaginally once every 12 weeks Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
All-Cause Mortality
Estring Testosterone Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Estring Testosterone Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Estring Testosterone Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/39 (25.64%)      10/36 (27.78%)    
General disorders     
Hot flashes  1  3/39 (7.69%)  3 1/36 (2.78%)  1
Reproductive system and breast disorders     
Vaginal discharge  1  4/39 (10.26%)  4 2/36 (5.56%)  2
Vaginal itching or irritation  1  4/39 (10.26%)  4 0/36 (0.00%)  0
Vaginal odor  1  0/39 (0.00%)  0 3/36 (8.33%)  3
Skin and subcutaneous tissue disorders     
Facial hair growth  1  1/39 (2.56%)  1 5/36 (13.89%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michelle Melisko, MD
Organization: University of California, San Francisco
Phone: 415-353-7070
EMail: mmelisko@medicine.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00698035     History of Changes
Other Study ID Numbers: UCSF-067519
First Submitted: June 11, 2008
First Posted: June 16, 2008
Results First Submitted: April 29, 2014
Results First Posted: June 2, 2014
Last Update Posted: June 2, 2014