Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment

Abbott

Status: Completed

Conditions: Metrorrhagia; Menorrhagia

Study type: Observational

Funder types: Industry

Identifiers

NCT01647360

P13-699

Details and patient eligibility

About

Dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.

In this study, women suffering from menorrhagia and who are treated with dydrogesterone will be observed for impact on QoL with the reduction in severity of bleeding.

Enrollment: 210 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Females aged 18 to 45 years
• Subjects presenting with Heavy Menstrual Bleeding (HMB)
• Subjects with Pictorial Blood Assessment Chart (PBAC) score of 100 or more
• Subjects will be treated with dydrogesterone in accordance to the local label after enrollment in the trial

Exclusion Criteria

• Subjects with structural or organic pathology as an underlying cause of HMB.
• Subjects with hypersensitivity to dydrogesterone
• Known or suspected progestogen dependent neoplasms
• Subjects with vaginal bleeding who have not been screened for organic or structural pathology as an underlying cause
• Subjects with acute or chronic liver disease
• Patients with depressive illness
• Subjects who are known to have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Nursing mothers
• Use of any other medication for uterine bleeding (including but not limited to progesterone, oral contraceptive pills, tranexamic acid etc)
• Use of Non-Steroidal Anti inflammatory Drugs (NSAIDs)

Trial design

210 participants in 1 patient group

Women with Heavy Menstrual Bleeding (HMB)