Trials / Recruiting
RecruitingNCT05478083
A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
Multicenter trial on the effect of the GnRH analogue leuprorelin on the growth of total liver volume in pre-menopausal women with very severe polycystic liver disease who, despite available therapy, experience growth and are heading for liver transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Leuprorelin | Treatment consist of leuprorelin 3.75 mg once monthly for the first 3 months followed by 3-monthly injections of 11.25 mg. The direct start group will use leuprorelin for 36 months. The delayed start group will use standard of care in the first 18 months. |
Timeline
- Start date
- 2022-06-01
- Primary completion
- 2027-06-01
- Completion
- 2027-10-01
- First posted
- 2022-07-28
- Last updated
- 2022-11-04
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05478083. Inclusion in this directory is not an endorsement.