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

May 27, 2013 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Federal Capital, Pakistan, 44000
        • Site reference ID/Investigator# 79836
      • Karachi, Sindh, Pakistan, 74000
        • Site Reference ID/Investigator# 77674
      • Karachi, Sindh, Pakistan, 74000
        • Site Reference ID/Investigator# 77675
      • Karachi, Sindh, Pakistan, 74000
        • Site reference ID/Investigator# 77676
      • Karachi, Sindh, Pakistan, 74000
        • Site Reference ID/Investigator# 77677
      • Karachi, Sindh, Pakistan, 74000
        • Site Reference ID/Investigator# 77680
      • Karachi, Sindh, Pakistan, 74000
        • Site Reference ID/Investigator# 77681
      • Lahore, Punjab, Pakistan, 54000
        • Site reference ID/Investigator # 77690
      • Lahore, Punjab, Pakistan, 54000
        • Site Reference ID/Investigator# 77691
      • Lahore, Punjab, Pakistan, 54000
        • Site reference ID/Investigator# 77694
      • Lahore, Punjab, Pakistan, 54000
        • Site Reference ID/Investigator# 77695
      • Lahore, Punjab, Pakistan, 54000
        • Site Reference ID/Investigator# 77696
      • Lahore, Punjab, Pakistan, 54000
        • Site reference ID/Investigator# 77698
      • Lahore, Punjab, Pakistan, 54000
        • Site Reference ID/Investigator# 77699
      • Multan, Punjab, Pakistan, 60000
        • Site Reference ID/Investigator# 77686
      • Multan, Punjab, Pakistan, 60000
        • Site Reference ID/Investigator# 77687
      • Multan, Punjab, Pakistan, 6000
        • Site Reference ID/Investigator# 77684
      • Multan, Punjab, Pakistan, 6000
        • Site Reference ID/Investigator# 77689
      • Rawalpindi, Punjab, Pakistan, 46000
        • Site reference ID/Investigator # 77693
      • Rawalpindi, Punjab, Pakistan, 46000
        • Site reference ID/Investigator# 79834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with heavy menstrual bleeding

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Women with Heavy Menstrual Bleeding (HMB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Raeef Ahmed, MD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimate)

July 23, 2012

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P13-699

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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