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

This study is currently recruiting participants.

Verified May 2013 by Abbott

Sponsor:

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01647360

First received: July 19, 2012

Last updated: May 3, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 19, 2012

Last Updated Date

May 3, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

EQ-5D Quality of Life questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01647360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pictorial Blood Assessment Chart (PBAC) score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change in the nature of menstruation will be taken into account based on the subjects' perception as recorded on the Menstrual Cycle Diary.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Women with heavy menstrual bleeding

Condition ^ICMJE

Menorrhagia
Metrorrhagia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Women with Heavy Menstrual Bleeding (HMB)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

210

Estimated Completion Date

November 2013

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Raeef Ahmed, MD	+92 21 32799230	raeef.ahmed@abbott.com
Contact: Irum Adil, MD	+92 21 32799228	irum.adil@abbott.com

Location Countries ^ICMJE

Pakistan

Administrative Information

NCT Number ^ICMJE

NCT01647360

Other Study ID Numbers ^ICMJE

P13-699

Has Data Monitoring Committee

Responsible Party

Abbott

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Raeef Ahmed, MD

Abbott

Information Provided By

Abbott

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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