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

Phase 4

Terminated

• Conditions: Uterine Leiomyoma
• Interventions: Drug: Dienogest; Drug: Goserelin; Drug: Desogestrel

• Registration Number: NCT01738724
• Lead Sponsor: University of Sao Paulo

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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-30
• Primary Completion: 2016-12
• Study Completion: 2017-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dienogest	Dienogest	Dienogest 2mg pills daily during 6 months
Goserelin	Goserelin	Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
Desogestrel	Desogestrel	Desogestrel 75mcg pills daily during six months

Primary Outcome Measures

Name	Time	Method
Leiomyoma Volume	After 6 months of medical therapy

Secondary Outcome Measures

Name	Time	Method
Pictorial Blood Assessment Chart (PBAC) Score Reduction	After 6 months of medical therapy
Number of episodes of vaginal bleeding	After 6 months of medical therapy