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Trial · NCT01126255

Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

NCT01126255, Phase 2, Terminated, Insel Gruppe AG, University Hospital Bern

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus. Trials, record NCT01126255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01126255

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Trial

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

Title
Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
NCT number
NCT01126255
Status
Terminated
Phases
Phase 2
Enrollment
37 participants, actual
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Conditions
Vulvar Lichen Sclerosus
Interventions
Clobetasol propionate 0.05%, Progesterone 8%
First posted
2010-05-19
Last updated
2022-04-01

Source ClinicalTrials.gov

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryScore of the characteristics of Lichen sclerosus based on vulvar efflorescencesat 12 weeks
The severity of the Lichen sclerosus will be assessed by a metric score, which is based on 6 items (abrasion, hyperkeratosis, rhagades, synechia, sclerosis, atrophy of labia/clitoris) consisting of three levels (0=no signs, 1=few signs, 2=pronounced signs).
SecondaryPatient-reported symptomsat baselineThe patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
SecondaryQuality of lifeat baselineThe patient will report quality of life on the SF12 questionnaire.
SecondaryAdverse eventsat baselineThe tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
SecondaryPatient-reported symptomsat 6 weeksThe patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.
SecondaryPatient-reported symptomsat 12 weeksThe patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.
SecondaryPatient-reported symptomsat 18 weeksThe patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
SecondaryPatient-reported symptomsat 24 weeksThe patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
SecondaryQuality of lifeat 12 weeksThe patient will report quality of life on the SF12 questionnaire.
SecondaryQuality of lifeat 24 weeksThe patient will report quality of life on the SF12 questionnaire.

Outcomes0

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

None in this release.

Results by group0

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

None in this release.

Participant flow0

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

None in this release.

Adverse events0

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

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
35290878RESULT

Source PubMed

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/NCT01126255

GET https://conductscience.org/api/trials/v1/NCT01126255/registered