Trial · NCT05478083
A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
NCT05478083, Phase 2, Recruiting, University Medical Center Groningen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease. Trials, record NCT05478083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05478083
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
- NCT number
- NCT05478083
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 36 participants, estimated
- Lead sponsor
- University Medical Center Groningen
- Conditions
- Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney
- Interventions
- Leuprorelin
- First posted
- 2022-07-28
- Last updated
- 2022-11-04
- Other registries' IDs
- eudract:2020-005949-16
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Liver growth | 36 months | Liver volumes (in % per year) measured in the MRI at screening, 6 months, 18 months, 24 months and 36 months |
| Secondary | Polycystic liver disease related complaints | 36 months | PLD related complaints assessed by the Polycystic liver disease-Questionnaire at baseline, 6 months, 18 months, 24 months and 36 months |
| Secondary | Menopause related complaints | 36 months | Menopause related complaints by using the validated MENQOL questionnaire at baseline, 6 months, 18 months, 24 months and 36 months |
| Secondary | Patient reported mental health | 36 months | Quality of life and as subset mental health will be measured by the validated RAND SF-36 questionnaires at baseline, 6 months, 18 months, 24 months and 36 months |
| Secondary | Patient reported physical health | 36 months | Quality of life and as subset physical health will be measured by the validated RAND SF-36 questionnaires at baseline, 6 months, 18 months, 24 months and 36 months |
| Secondary | Kidney growth | 36 months | Kidney volumes (in % per year) measured in the MRI at screening, 6 months, 18 months, 24 months and 36 months |
| Secondary | Sex hormone levels | 36 months | Anti Muller Hormone will be assessed at screening. Other Extensive laboratory includes estradiol, progesterone, AMH, FSH, LH levels at baseline, 6 months after start therapy and after 18 and 36 months. |
| Secondary | Bone density | 36 months | Bone density measured by a DEXA scan at screening, 18 months and 36 months. |
| Secondary | Renal function | 36 months | eGFR measurements and 24h urine analyisis (in ADPKD patients only) at baseline, 6 months, 18 months, 24 months and 36 months time |
| Secondary | Bloodpressure | 36 months | Manual blood pressure measurements in millimetres of mercury (measure 3 times with 2 minutes in between) at screening, baseline, 3 months, 6 months, 12 months, 18months, 21 months, 24 months, 30 months and 36 months . |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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.
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.
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/NCT05478083
GET https://conductscience.org/api/trials/v1/NCT05478083/registered