Study Stopped
PI went for a post-doc course and when he came back he moved for another job
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
1 other identifier
interventional
14
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2012
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 23, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 13, 2020
August 1, 2020
4.9 years
November 23, 2012
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Leiomyoma Volume
After 6 months of medical therapy
Secondary Outcomes (2)
Pictorial Blood Assessment Chart (PBAC) Score Reduction
After 6 months of medical therapy
Number of episodes of vaginal bleeding
After 6 months of medical therapy
Study Arms (3)
Dienogest
EXPERIMENTALDienogest 2mg pills daily during 6 months
Goserelin
EXPERIMENTALGoserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
Desogestrel
ACTIVE COMPARATORDesogestrel 75mcg pills daily during six months
Interventions
Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
Eligibility Criteria
You may qualify if:
- Women with 35 - 55 years of age
- Uterine volume between 50cc and 500cc
- Abnormal uterine bleeding probably associated to intramural uterine leiomyomas
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luiz Gustavo O Brito, MD, PhD
FMRP-USP
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Physician, MD, PhD
Study Record Dates
First Submitted
November 23, 2012
First Posted
November 30, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
August 13, 2020
Record last verified: 2020-08