Dienogest for Treatment of Adenomyotic Uteri

Study Overview
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Brief Summary
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Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Other treatment options are increasingly offered, including hormonal suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation. However, deep adenomyosis responds weakly to the above treatment options, which are commonly not considered for long-term management because of the associated side effects. Dienogest is a progestin medication which is used in birth control pills and in the treatment of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been widely used as the primary treatment for menorrhagia. COCs can also be used to induce endometrial atrophy and to decrease endometrial prostaglandin production, which can consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis

Official Title
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Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri

Conditions
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Adenomyosis

Intervention / Treatment
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* Drug: Dienogest group
* Drug: Gestodene-Ethinyl Estradiol
* Radiation: Ultrasound
* Other: visual analogue scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 20-40 years Women with ultrasonographic evidence of adenomyosis Woman complains of vaginal bleeding or pelvic pain related to adenomyosis Exclusion Criteria: Women with a history of malignancy or histological evidence of endometrial hyperplasia any adnexal abnormality on ultrasound undiagnosed vaginal contraindication to receive Vissane or gynera .

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: Dienogest group<br> | Drug: Dienogest group<br>* VISANNE 2MG Tablet once daily<br>Radiation: Ultrasound<br>* ultrasound assessment of uterine volume<br>Other: visual analogue scale<br>* visual analogue scale for assessment of pain<br>|
| Active Comparator: Gynera group<br> | Drug: Gestodene-Ethinyl Estradiol<br>* Gynera tablet once daily<br>Radiation: Ultrasound<br>* ultrasound assessment of uterine volume<br>Other: visual analogue scale<br>* visual analogue scale for assessment of pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women who will improved from the pelvic pain measured by visual analogue scale |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine volume (cm 3 ) measure by ultrasound |  | 6 month |