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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01647360
First received: July 19, 2012
Last updated: May 27, 2013
Last verified: May 2013

July 19, 2012
May 27, 2013
June 2012
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01647360 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Women with heavy menstrual bleeding

  • Menorrhagia
  • Metrorrhagia
Not Provided
Women with Heavy Menstrual Bleeding (HMB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
May 2013
May 2013   (final data collection date for primary outcome measure)

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)
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01647360
P13-699
No
Abbott
Abbott
Not Provided
Study Director: Raeef Ahmed, MD Abbott
Abbott
May 2013

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