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

This study is not yet open for participant recruitment.

Verified November 2012 by University of Sao Paulo

Sponsor:

Information provided by (Responsible Party):

LUIZ GUSTAVO OLIVEIRA BRITO, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01738724

First received: November 23, 2012

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Purpose

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	Intervention	Phase
Uterine Leiomyoma	Drug: Dienogest Drug: Goserelin Drug: Desogestrel	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Desogestrel Goserelin Dienogest Goserelin acetate

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Leiomyoma Volume [ Time Frame: After 6 months of medical therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pictorial Blood Assessment Chart (PBAC) Score Reduction [ Time Frame: After 6 months of medical therapy ] [ Designated as safety issue: No ]
Number of episodes of vaginal bleeding [ Time Frame: After 6 months of medical therapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	63
Study Start Date:	January 2013
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Zoladex
Active Comparator: Desogestrel Desogestrel 75mcg pills daily during six months	Drug: Desogestrel Desogestrel 75mcg pills daily during six months Other Name: Cerazette

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.

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738724

Contacts

Contact: Luiz Gustavo O Brito, MD, PhD	+551636021000	lbrito@usp.br
Contact: Rafael M Moroni, MD	+551636021000	rafaelmmoroni@gmail.com

Sponsors and Collaborators

University of Sao Paulo

Investigators

Study Chair:

Luiz Gustavo O Brito, MD, PhD

FMRP-USP

More Information

No publications provided

Responsible Party:	LUIZ GUSTAVO OLIVEIRA BRITO, Assistant Physician, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01738724 History of Changes
Other Study ID Numbers:	FMRPUSP-UROGIN-002
Study First Received:	November 23, 2012
Last Updated:	November 27, 2012
Health Authority:	Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:

Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Desogestrel
Dienogest
Goserelin
Progestins
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on May 19, 2013

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