Trial · NCT01256671
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
NCT01256671, Phase 3, Completed, EndoCeutics Inc.; results first posted 2017-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. DHEA Against Vaginal Atrophy - Safety Study of 12 Months. Trials, record NCT01256671. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256671
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DHEA Against Vaginal Atrophy - Safety Study of 12 Months
- NCT number
- NCT01256671
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 530 participants, actual
- Lead sponsor
- EndoCeutics Inc.
- Conditions
- Vaginal Atrophy
- Interventions
- DHEA
- First posted
- 2010-12-08
- Last updated
- 2017-10-18
- Results first posted
- 2017-10-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium | Baseline and Week 52 (or discontinuation) | The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented. |
| Primary | Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels | Baseline and Week 52 | The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. |
| Secondary | Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | Baseline and Week 52 | The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. |
| Secondary | Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). | Baseline and Week 52 | The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. |
| Secondary | Change From Baseline to Week 52 of Vaginal pH. | Baseline and Week 52 | A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. |
| Secondary | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia | Baseline and Week 52 | The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. |
| Secondary | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness | Baseline and Week 52 | The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. |
| Secondary | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching | Baseline and Week 52 | The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium | Baseline and Week 52 (or discontinuation) | Only subjects in the Safety Population who had an end-of-study endometrial biopsy are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | Baseline and Week 52 | Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)). | percentage of parabasal cells | MEAN |
| SECONDARY | Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). | Baseline and Week 52 | Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)). | percentage of superficial cells | MEAN |
| SECONDARY | Change From Baseline to Week 52 of Vaginal pH. | Baseline and Week 52 | Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS)). | pH | MEAN |
| SECONDARY | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia | Baseline and Week 52 | Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS dyspareunia only includes subjects having MS dyspareunia (being or not most bothersome (MBS)) (n=240); the analysis MBS/MS only includes subjects with MS dyspareunia being MBS (n=183). | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness | Baseline and Week 52 | Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS only includes subjects having MS dryness (being or not most bothersome (MBS)) (n=251); the analysis MBS/MS only includes subjects with MS dryness being MBS (n=81). | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching | Baseline and Week 52 | Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS only includes subjects having MS irritation/itching (being or not most bothersome (MBS)) (n=86); the analysis MBS/MS only includes subjects with MS irritation/itching being MBS (n=23). | units on a scale | MEAN |
| PRIMARY | Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels | Baseline and Week 52 | Data are presented for subjects in the Safety Population who have steroid data at both baseline and Week 52. | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium | 0.50% DHEA | Endometrium: Atrophic/Inactive | 421 | Participants | |
| Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium | 0.50% DHEA | Endometrium: No/Insufficient Tissue for Diagnosis | 36 | Participants | |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | 0.50% DHEA | Baseline: Subgroup ALL | 55.49 | Standard Error 2.03 | percentage of parabasal cells |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | 0.50% DHEA | Week 52: Subgroup ALL | 12.81 | Standard Error 0.97 | percentage of parabasal cells |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | 0.50% DHEA | Change from Baseline: Subgroup ALL | -42.67 | Standard Error 1.84 | percentage of parabasal cells |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | 0.50% DHEA | Baseline: Subgroup VVA | 63.95 | Standard Error 2.41 | percentage of parabasal cells |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | 0.50% DHEA | Week 52: Subgroup VVA | 14.80 | Standard Error 1.27 | percentage of parabasal cells |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). | 0.50% DHEA | Change from Baseline: Subgroup VVA | -49.14 | Standard Error 2.22 | percentage of parabasal cells |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). | 0.50% DHEA | Baseline: Subgroup ALL | 2.02 | Standard Error 0.19 | percentage of superficial cells |
| Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). | 0.50% DHEA | Week 52: Subgroup ALL | 9.42 | Standard Error 0.36 | percentage of superficial cells |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.50% DHEA | 530 | |
| Overall Study | Safety Population | 0.50% DHEA | 521 | |
| Overall Study | COMPLETED | 0.50% DHEA | 435 | |
| Overall Study | NOT COMPLETED | 0.50% DHEA | 95 |
Source ClinicalTrials.gov
Adverse events26
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 | Application site discharge | General disorders | 0.50% DHEA | 73 | 521 | |
| other | Nasopharyngitis | Infections and infestations | 0.50% DHEA | 51 | 521 | |
| other | Urinary tract infection | Infections and infestations | 0.50% DHEA | 53 | 521 | |
| serious | Colitis ischaemic | Gastrointestinal disorders | 0.50% DHEA | 1 | 521 | |
| serious | Duodenal stenosis | Gastrointestinal disorders | 0.50% DHEA | 1 | 521 | |
| serious | Dyspepsia | Gastrointestinal disorders | 0.50% DHEA | 1 | 521 | |
| serious | Pancreatitis | Gastrointestinal disorders | 0.50% DHEA | 1 | 521 | |
| serious | Infectious peritonitis | Infections and infestations | 0.50% DHEA | 1 | 521 | |
| serious | Staphylococcal infection | Infections and infestations | 0.50% DHEA | 1 | 521 | |
| serious | Femur fracture | Injury, poisoning and procedural complications | 0.50% DHEA | 1 | 521 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.50% DHEA | ||
| Total, other adverse events | 0.50% DHEA | 177 | 521 |
| Total, serious adverse events | 0.50% DHEA | 18 | 521 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT01256671
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