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

August 11, 2020 updated by: LUIZ GUSTAVO OLIVEIRA BRITO, University of Sao Paulo

Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dienogest
Dienogest 2mg pills daily during 6 months
Drug: Dienogest
Dienogest 2mg pills daily during 6 months
Other Names:
  • Visanne
  • Allurene
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Leiomyoma Volume
Time Frame: After 6 months of medical therapy
After 6 months of medical therapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 23, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMRPUSP-UROGIN-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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