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Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin

Sponsor
University of Sao Paulo (Other)
Overall Status
Terminated
CT.gov ID
NCT01738724
Collaborator
(none)
14
Enrollment
3
Arms
71
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Uterine leiomyoma is a very prevalent condition among women and, although it is mainly asymptomatic, it may be related to bothersome or debilitating symptoms, such as uterine bleeding and pelvic pain or pressure. The standard treatment is surgical (hysterectomy or myomectomy), but there has been continued interest on medical treatments. Progestagens have long been used to control bleeding associated to leiomyomas, but they have not been able to decrease myoma volume. GnRH analogs are well stablished agents, capable of controlling symptoms and decreasing the tumors´volume, but their use is limited by bone loss and menopausal symptoms. A newly introduced progestagen, dienogest, has been studied to treat endometriosis, but its effects on leiomyoma are only starting to be assessed. The investigators are aiming to compare dienogest with the GnRH analog goserelin and the progestagen desogestrel in a randomized trial to see how this new treatment compares with previously used drugs and whether it is similar, inferior or superior to them on controlling leiomyoma associated symptoms and decreasing leiomyoma volume.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dienogest

Dienogest 2mg pills daily during 6 months

Drug: Dienogest
Dienogest 2mg pills daily during 6 months
Other Names:
  • Allurene
  • Visanne

    		•
    Experimental: Goserelin

    Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months

    Drug: Goserelin
    Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
    Other Names:
  • Zoladex

    		•
    Active Comparator: Desogestrel

    Desogestrel 75mcg pills daily during six months

    Drug: Desogestrel
    Desogestrel 75mcg pills daily during six months
    Other Names:
  • Cerazette

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Leiomyoma Volume [After 6 months of medical therapy]

    Secondary Outcome Measures

    1. Pictorial Blood Assessment Chart (PBAC) Score Reduction [After 6 months of medical therapy]

    2. Number of episodes of vaginal bleeding [After 6 months of medical therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    • Study Chair: Luiz Gustavo O Brito, MD, PhD, FMRP-USP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LUIZ GUSTAVO OLIVEIRA BRITO, Assistant Physician, MD, PhD, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT01738724
    Other Study ID Numbers:
    • FMRPUSP-UROGIN-002
    First Posted:
    Nov 30, 2012
    Last Update Posted:
    Aug 13, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Goserelin
    Dienogest
    Desogestrel

    Study Results

    No Results Posted as of Aug 13, 2020