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

Menorrhagia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647360
• Other study ID #: P13-699
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: May 27, 2013
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menorrhagia
• Metrorrhagia

Locations

Country	Name	City	State
Pakistan	Site reference ID/Investigator# 79836	Islamabad, Federal Capital
Pakistan	Site Reference ID/Investigator# 77674	Karachi, Sindh
Pakistan	Site Reference ID/Investigator# 77675	Karachi, Sindh
Pakistan	Site reference ID/Investigator# 77676	Karachi, Sindh
Pakistan	Site Reference ID/Investigator# 77677	Karachi, Sindh
Pakistan	Site Reference ID/Investigator# 77680	Karachi, Sindh
Pakistan	Site Reference ID/Investigator# 77681	Karachi, Sindh
Pakistan	Site reference ID/Investigator # 77690	Lahore, Punjab
Pakistan	Site Reference ID/Investigator# 77691	Lahore, Punjab
Pakistan	Site reference ID/Investigator# 77694	Lahore, Punjab
Pakistan	Site Reference ID/Investigator# 77695	Lahore, Punjab
Pakistan	Site Reference ID/Investigator# 77696	Lahore, Punjab
Pakistan	Site reference ID/Investigator# 77698	Lahore, Punjab
Pakistan	Site Reference ID/Investigator# 77699	Lahore, Punjab
Pakistan	Site Reference ID/Investigator# 77684	Multan, Punjab
Pakistan	Site Reference ID/Investigator# 77686	Multan, Punjab
Pakistan	Site Reference ID/Investigator# 77687	Multan, Punjab
Pakistan	Site Reference ID/Investigator# 77689	Multan, Punjab
Pakistan	Site reference ID/Investigator # 77693	Rawalpindi, Punjab
Pakistan	Site reference ID/Investigator# 79834	Rawalpindi, Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EQ-5D Quality of Life questionnaire	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.	3 months	No
Secondary	Pictorial Blood Assessment Chart (PBAC) score	PBAC score of 100 or more corresponds with heavy menstrual bleeding. PBAC score will be assessed at each visit to see any improvement.	3 months	No
Secondary	Menstrual Cycle Diary	Change in the nature of menstruation will be taken into account based on the subjects' perception as recorded on the Menstrual Cycle Diary.	3 months	No