Trial · NCT01376349

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

NCT01376349, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-08-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms. Trials, record NCT01376349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01376349

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms
NCT number: NCT01376349
Status: Completed
Phases: Phase 3
Enrollment: 464 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Breast Cancer, Gynecologic Cancer
Interventions: prasterone, placebo
First posted: 2011-06-20
Last updated: 2019-02-07
Results first posted: 2017-08-25

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks	At baseline and 12 weeks	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).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks	At baseline and 12 weeks	All patients that started treatment and completed their week 12 evaluation are included in this analysis.	change in units on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks	Arm I Low Dose DHEA	-2	Full Range -4 to 1	change in units on a scale
Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks	Arm II High Dose DHEA	-2	Full Range -4 to 1	change in units on a scale
Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks	Arm III Placebo	-1	Full Range -4 to 1	change in units on a scale

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Raondomized Treatment	STARTED	Arm I Low Dose DHEA	147
Raondomized Treatment	STARTED	Arm II High Dose DHEA	149
Raondomized Treatment	STARTED	Arm III Placebo	147
Raondomized Treatment	COMPLETED	Arm I Low Dose DHEA	123
Raondomized Treatment	COMPLETED	Arm II High Dose DHEA	114
Raondomized Treatment	COMPLETED	Arm III Placebo	118
Raondomized Treatment	NOT COMPLETED	Arm I Low Dose DHEA	24
Raondomized Treatment	NOT COMPLETED	Arm II High Dose DHEA	35
Raondomized Treatment	NOT COMPLETED	Arm III Placebo	29
Optional Continuation Phase	STARTED	Arm I Low Dose DHEA	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events248

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Arm I: Low Dose DHEA	1	147	1
other	Anemia	Blood and lymphatic system disorders	Arm II: High Dose DHEA	0	148	0
other	Anemia	Blood and lymphatic system disorders	Arm III: Placebo	0	147	0
other	Anemia	Blood and lymphatic system disorders	Optional Continuation Phase	0	94	0
other	Atrial fibrillation	Cardiac disorders	Arm I: Low Dose DHEA	0	147	0
other	Atrial fibrillation	Cardiac disorders	Arm II: High Dose DHEA	1	148	1
other	Atrial fibrillation	Cardiac disorders	Arm III: Placebo	0	147	0
other	Atrial fibrillation	Cardiac disorders	Optional Continuation Phase	0	94	0
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm I: Low Dose DHEA	0	147	0
other	Cardiac disorders - Other, specify	Cardiac disorders	Arm II: High Dose DHEA	0	148	0

1 to 10 of 248Source ClinicalTrials.gov

See all 248 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I: Low Dose DHEA
Total, all-cause mortality	Arm II: High Dose DHEA
Total, all-cause mortality	Arm III: Placebo
Total, all-cause mortality	Optional Continuation Phase
Total, other adverse events	Arm I: Low Dose DHEA	91	147
Total, other adverse events	Arm II: High Dose DHEA	105	148
Total, other adverse events	Arm III: Placebo	93	147
Total, other adverse events	Optional Continuation Phase	28	94
Total, serious adverse events	Arm I: Low Dose DHEA	3	147
Total, serious adverse events	Arm II: High Dose DHEA	7	148

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01376349

GET https://conductscience.org/api/trials/v1/NCT01376349/events?page=2

API reference For AI assistants