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

Overview

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.

Full Title of Study: “Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

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.

Interventions

  • Drug: Dienogest
    • Dienogest 2mg pills daily during 6 months
  • Drug: Goserelin
    • Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
  • Drug: Desogestrel
    • Desogestrel 75mcg pills daily during six months

Arms, Groups and Cohorts

  • Experimental: Dienogest
    • Dienogest 2mg pills daily during 6 months
  • Experimental: Goserelin
    • Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
  • Active Comparator: Desogestrel
    • Desogestrel 75mcg pills daily during six months

Clinical Trial Outcome Measures

Primary Measures

  • Leiomyoma Volume
    • Time Frame: After 6 months of medical therapy

Secondary Measures

  • Pictorial Blood Assessment Chart (PBAC) Score Reduction
    • Time Frame: After 6 months of medical therapy
  • Number of episodes of vaginal bleeding
    • Time Frame: After 6 months of medical therapy

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 35 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: LUIZ GUSTAVO OLIVEIRA BRITO, Assistant Physician, MD, PhD – University of Sao Paulo
  • Overall Official(s)
    • Luiz Gustavo O Brito, MD, PhD, Study Chair, FMRP-USP

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