Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis

Ipsen

Status: Completed

Conditions: Internal Endometriosis

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT03586063

A-38-52014-191

Details and patient eligibility

About

To describe Gonadotropin-Releasing Hormone agonists (GnRH-a) treatment effectiveness on reduction of internal genital endometriosis symptom - menorrhagia - in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3,75 mg - assessment performed six months after the last injection.

Enrollment: 465 patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premenopausal women aged 25-40 years old
• With symptomatic internal genital endometriosis - at least mild menorrhagia present or worse
• Internal genital endometriosis diagnosis is based on enlarged uterus detected by pelvic bimanual examination and ultrasound examination (stages I-II-III by Demidov in accordance with ultrasound results not earlier than 2 months before first injection
• Naive patients who have never been prescribed a GnRH agonist

Exclusion criteria

• Pregnant subjects
• Subjects with hypersensitivity to GnRH analogue or to one of its excipients
• Subjects treated with any other investigational drug within the last 30 days before study entry
• Subjects' refusal to participate in the study