The effectiveness of Dienogest in reducing dysmenorrhea

Phase 3

Recruiting

• Conditions: Dysmenorrhea.; Dysmenorrhea, unspecified; N94.6

• Registration Number: IRCT20150105020558N5
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

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

Inclusion Criteria

20 to 45 years old
Noticeable pain (Visual Analogue Scale>=4) in the lower abdomen or pelvic area during menstruation in the last six months
With regular mensuration cycles
With normal genital system physical examination and ultrasound

Exclusion Criteria

Withdrawal to participation
Patients with adenomyosis, submucosal myoma, or endometriosis
Patients with abnormal serum lipid profile
Patients with underlying diseases or chronic pelvic pain

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dysmenorrhea. Timepoint: Four times (once before the intervention and three times after the intervention) every four weeks. Method of measurement: Visual Analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Estrogen levels. Timepoint: Before the intervention and at the end of the study. Method of measurement: Serum Estradiol (E2) measurement.;Premenstrual symptoms. Timepoint: Four times (once before the intervention and three times after the intervention) every four weeks. Method of measurement: Menstrual Distress Questionnaire.;Dienogest side effects. Timepoint: Four times (once before the intervention and three times after the intervention) every four weeks. Method of measurement: Patient interview.