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

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Site reference ID/Investigator# 79836, Islamabad, Federal Capital, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

EQ-5D Quality of Life questionnaire

Time frame: 3 months

The EQ-5D assesses five dimensions of HRQOL: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is measured on a three-point ordinal scale where a higher score corresponds to a worse health state (no limitation, some limitation, and greatest limitation in HRQOL). This will be evaluated at baseline and then at each follow up visit to see impact on quality of life.

Secondary outcomes

Pictorial Blood Assessment Chart (PBAC) score

Time frame: 3 months

PBAC score of 100 or more corresponds with heavy menstrual bleeding. PBAC score will be assessed at each visit to see any improvement.
Menstrual Cycle Diary

Time frame: 3 months

Change in the nature of menstruation will be taken into account based on the subjects' perception as recorded on the Menstrual Cycle Diary.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Post- Marketing, Prospective,Multicenter, Observational Program: Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jul 23, 2012
Registry last updated: May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed