Dienogest for Treatment of Adenomyotic Uteri

Not Applicable

Completed

• Conditions: Adenomyosis
• Interventions: Drug: Dienogest group; Drug: Gestodene-Ethinyl Estradiol; Radiation: Ultrasound; Other: visual analogue scale

• Registration Number: NCT03890042
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-23
• Study First Submitted QC: 2019-03-23
• Study First Posted: 2019-03-26
• Primary Completion: 2020-07-01
• Status Verified: 2020-08
• Study Completion: 2020-08-01
• Last Update Submitted: 2020-08-22
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dienogest group	Dienogest group	-
Dienogest group	Ultrasound	-
Dienogest group	visual analogue scale	-
Gynera group	Gestodene-Ethinyl Estradiol	-
Gynera group	Ultrasound	-
Gynera group	visual analogue scale	-

Primary Outcome Measures

Name	Time	Method
Number of women who will improved from the pelvic pain measured by visual analogue scale	6 months

Secondary Outcome Measures

Name	Time	Method
Uterine volume (cm 3 ) measure by ultrasound	6 month

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt