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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
  Purpose

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.


Condition
Menorrhagia
Metrorrhagia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 210
Study Start Date: June 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with Heavy Menstrual Bleeding (HMB)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women with heavy menstrual bleeding

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647360

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

Locations
Pakistan
Site Reference ID/Investigator# 77674 Recruiting
Karachi, Sindh, Pakistan, 74000
Principal Investigator: Site Reference ID/Investigator# 77674            
Site Reference ID/Investigator# 77675 Recruiting
Karachi, Sindh, Pakistan, 74000
Principal Investigator: Site Reference ID/Investigator# 77675            
Site Reference ID/Investigator# 77677 Recruiting
Karachi, Sindh, Pakistan, 74000
Principal Investigator: Site Reference ID/Investigator# 77677            
Site Reference ID/Investigator# 77680 Recruiting
Karachi, Sindh, Pakistan, 74000
Principal Investigator: Site Reference ID/Investigator# 77680            
Site Reference ID/Investigator# 77681 Recruiting
Karachi, Sindh, Pakistan, 74000
Principal Investigator: Site Reference ID/Investigator# 77681            
Site Reference ID/Investigator# 77699 Recruiting
Lahore, Punjab, Pakistan, 54000
Principal Investigator: Site Reference ID/Investigator# 77699            
Site Reference ID/Investigator# 77691 Recruiting
Lahore, Punjab, Pakistan, 54000
Principal Investigator: Site Reference ID/Investigator# 77691            
Site Reference ID/Investigator# 77695 Recruiting
Lahore, Punjab, Pakistan, 54000
Principal Investigator: Site Reference ID/Investigator# 77695            
Site Reference ID/Investigator# 77696 Recruiting
Lahore, Punjab, Pakistan, 54000
Principal Investigator: Site Reference ID/Investigator# 77696            
Site Reference ID/Investigator# 77684 Recruiting
Multan, Punjab, Pakistan, 6000
Principal Investigator: Site Reference ID/Investigator# 77684            
Site Reference ID/Investigator# 77687 Recruiting
Multan, Punjab, Pakistan, 60000
Principal Investigator: Site Reference ID/Investigator# 77687            
Site Reference ID/Investigator# 77689 Recruiting
Multan, Punjab, Pakistan, 6000
Principal Investigator: Site Reference ID/Investigator# 77689            
Site Reference ID/Investigator# 77686 Recruiting
Multan, Punjab, Pakistan, 60000
Principal Investigator: Site Reference ID/Investigator# 77686            
Sponsors and Collaborators
Abbott
Investigators
Study Director: Raeef Ahmed, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01647360     History of Changes
Other Study ID Numbers: P13-699
Study First Received: July 19, 2012
Last Updated: May 3, 2013
Health Authority: Pakistan: Ministry of Health

Keywords provided by Abbott:
Metrorrhagia
Menorrhagia

Additional relevant MeSH terms:
Hemorrhage
Menorrhagia
Metrorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
 Menstruation Disturbances
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013