Clinical trial · Interventional
Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin
Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI went for a post-doc course and when he came back he moved for another job
Summary
Brief summary (as posted)
The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH) analogs or the progestagen desogestrel or whether it is inferior to other drugs already in use.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Leiomyoma | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Desogestrel | Drug | — | UNRESOLVED |
| Dienogest | Drug | — | UNRESOLVED |
| Goserelin | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dienogest
- description
- Dienogest 2mg pills daily during 6 months
- interventionNames
- Drug: Dienogest
- type
- EXPERIMENTAL
- label
- Goserelin
- description
- Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
- interventionNames
- Drug: Goserelin
- type
- ACTIVE_COMPARATOR
- label
- Desogestrel
- description
- Desogestrel 75mcg pills daily during six months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Women with 35 - 55 years of age * Uterine volume between 50cc and 500cc * Abnormal uterine bleeding probably associated to intramural uterine leiomyomas Exclusion Criteria: * Pregnancy * Liver or kidney dysfunction * Women with only submucosal or subserosal uterine leiomyomas * Women with contraindications to any of the drugs (categories 3 and 4 of WHO eligibility criteria) * Use of anticoagulants * Others causes of abnormal uterine bleeding (endometrial pathology, cervical pathology)
References
Publications (0)
Data not yet available