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Trial · Interventional

TerminatedPhase 4Registry data

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

NCTNCT01738724 (opens ClinicalTrials.gov in a new tab)Other idFMRPUSP-UROGIN-002
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Overview

Status
Terminated
Phase
Phase 4
Enrollment
14 participants (actual)
Sponsor
University of Sao Paulo · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
Jan 2012
Primary completion
Dec 2016
Completion
Dec 2017
First posted
30 Nov 2012 (estimated)
Last update posted
13 Aug 2020
Conditions
Uterine Leiomyoma

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015201620172018
  1. Ph 4

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

    NCT01738724

    Jan 2012 to Dec 2017

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DienogestDrug
  • GoserelinDrug
  • DesogestrelDrug

Arms3

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Leiomyoma Volume

    Time frame · After 6 months of medical therapy

Secondary outcomes(2)

  1. Pictorial Blood Assessment Chart (PBAC) Score Reduction

    Time frame · After 6 months of medical therapy

  2. Number of episodes of vaginal bleeding

    Time frame · After 6 months of medical therapy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 35 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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