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

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ClinicalTrials.gov Identifier: NCT01738724
Recruitment Status : Unknown
Verified November 2012 by LUIZ GUSTAVO OLIVEIRA BRITO, University of Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Leiomyoma Drug: Dienogest Drug: Goserelin Drug: Desogestrel Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Leiomyoma Volume [ Time Frame: After 6 months of medical therapy ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738724

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

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
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anabolic Agents
Contraceptives, Oral, Synthetic