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

Uterine Leiomyoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01738724
• Other study ID #: FMRPUSP-UROGIN-002
• Status: Terminated
• Phase: Phase 4
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: August 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leiomyoma Volume		After 6 months of medical therapy
Secondary	Pictorial Blood Assessment Chart (PBAC) Score Reduction		After 6 months of medical therapy
Secondary	Number of episodes of vaginal bleeding		After 6 months of medical therapy