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

NCT01738724 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-08-13

No results posted yet for this study

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.

Conditions

  • Uterine Leiomyoma

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

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Luiz Gustavo O Brito, MD, PhD · FMRP-USP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-12-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01738724 on ClinicalTrials.gov