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

Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01738724
Enrollment
14
Registered
2012-11-30
Start date
2012-01-31
Completion date
2017-12-31
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Leiomyoma

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.

Interventions

Dienogest 2mg pills daily during 6 months

DRUGGoserelin

Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months

Desogestrel 75mcg pills daily during six months

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 55 Years
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)

Design outcomes

Primary

MeasureTime frame
Leiomyoma VolumeAfter 6 months of medical therapy

Secondary

MeasureTime frame
Pictorial Blood Assessment Chart (PBAC) Score ReductionAfter 6 months of medical therapy
Number of episodes of vaginal bleedingAfter 6 months of medical therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026