Dienogest for Treatment of Adenomyotic Uteri

Adenomyosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890042
• Other study ID #: DAD
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 1, 2020

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Drug:
• Dienogest group
VISANNE 2MG Tablet once daily
• Gestodene-Ethinyl Estradiol
Gynera tablet once daily

Radiation:
• Ultrasound
ultrasound assessment of uterine volume

Other:
• visual analogue scale
visual analogue scale for assessment of pain

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of women who will improved from the pelvic pain measured by visual analogue scale		6 months
Secondary	Uterine volume (cm 3 ) measure by ultrasound		6 month