Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan

Abbott

Status: Completed

Conditions: Irregular Menstrual Cycle

Study type: Observational

Funder types: Industry

Identifiers

NCT01711216

P13-688

Details and patient eligibility

About

Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. There are limited data regarding dydrogesterone's role in achieving cycle regularization from post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in a post-marketing setting after cessation of treatment and whether the persistence, if any, is related to the duration of dydrogesterone therapy. Hence, in this observational program, the goal is to observe the possible implications of such treatment in terms of treatment length and response pattern.

Full description

The program is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing program. Being an observational program, the assignment of patients to dydrogesterone therapy will not be decided with an intention to include patients in the program, but will be guided as per standard clinical practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly separate from the decision to include patients in this program. All dydrogesterone prescriptions will be made in accordance with locally approved package insert for dydrogesterone.

Enrollment: 999 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Women aged 18-40 years
• Irregular menstrual cycle due to progesterone deficiency for at least 3 months
• Dydrogesterone prescribed in accordance with locally approved package insert
• Signed written authorization to provide data for the program

Exclusion Criteria

• Known hypersensitivity to the active ingredient or excipients
• Known or suspected progesterone-dependent neoplasms
• Vaginal bleeding of unknown etiology
• Administration of oral contraceptives
• Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)

Trial design

999 participants in 1 patient group

women received dydrogesterone for irregular menstrual cycle

Description:

Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician