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The effectiveness of Dienogest in reducing dysmenorrhea

Evaluation of the effectiveness of Dienogest compared to placebo in reducing dysmenorrhea in women with primary and secondary dysmenorrhea

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150105020558N5
Enrollment
60
Registered
2022-09-18
Start date
2022-10-23
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea. Dysmenorrhea, unspecified

Interventions

Intervention 1: Intervention group: For this group of patients, 0.5 milligrams Dienogest (one-quarter of a tablet produced by the Aburihan pharmaceutical factory named Dinovol) is prescribed twice a d

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahbod Ebrahimi

Tehran University of Medical Sciences

maebrahimi@tums.ac.ir+98 21 8882 7794

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026