Comparative study of dienogest and danazol in endometrial preparatio

Phase 3

Recruiting

• Conditions: Intrauterine myoma.; Leiomyoma of uterus, unspecified; D25.9

• Registration Number: IRCT20110523006563N4
• Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Reproductive ages
Moderate to moderate abnormal uterine bleeding
Do not receive hormonal medication for 8 weeks
Submucosal myoma 30 mm or less in diameter in transvaginal ultrasound
Submucosal myoma grade zero or I according to the classification of the European Society of Endoscopy and Gynecology

Exclusion Criteria

Cardiovascular disease
Hepatic disease
Renal disease
Pulmonary disease
Hematologic disease
Hypertension
Diabetes
High triglyceride
Thromboembolism
History of uterine and cervical cancer
History of submucosal leiomyoma larger than 3 cm
History of acute genital infection
History of the uterine septum
Pregnancy
Infertility
Requires transfusion
Severe bleeding
Using anticoagulants

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endometrial atrophy. Timepoint: 4 weeks after the intervention. Method of measurement: Vaginal ultrasound.;Bleeding during surgery. Timepoint: After surgery. Method of measurement: Operating room suction.

Secondary Outcome Measures

Name	Time	Method
Clear image resolution. Timepoint: During surgery. Method of measurement: Observed by a gynecological surgeon.;Operation duration. Timepoint: During surgery. Method of measurement: Observed by a gynecological surgeon.;Success rate of myomectomy. Timepoint: During surgery. Method of measurement: Observed by a gynecological surgeon.