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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01647360

Enrollment

210

Registered

2012-07-23

Start date

2012-06-30

Completion date

2013-05-31

Last updated

2013-05-29

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

Conditions

Menorrhagia, Metrorrhagia

Keywords

Metrorrhagia, Menorrhagia

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
EQ-5D Quality of Life questionnaire	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

Measure	Time frame	Description
Pictorial Blood Assessment Chart (PBAC) score	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	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.

Countries

Pakistan

Outcome results