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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Leiomyoma

Intervention / Treatment
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* Drug: Dienogest
* Drug: Goserelin
* Drug: Desogestrel


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dienogest<br>Dienogest 2mg pills daily during 6 months | Drug: Dienogest<br>* Dienogest 2mg pills daily during 6 months<br>* Other names: Visanne;|
| Experimental: Goserelin<br>Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months | Drug: Goserelin<br>* Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months<br>* Other names: Zoladex;|
| Active Comparator: Desogestrel<br>Desogestrel 75mcg pills daily during six months | Drug: Desogestrel<br>* Desogestrel 75mcg pills daily during six months<br>* Other names: Cerazette;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leiomyoma Volume |  | After 6 months of medical therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |