NCT01647360|Completed

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

Abbott ClinicalTrials.gov

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1 other identifier

P13-699

Study Type

observational

Target

210

Locations

1 country

Sites

Timeline

RegisteredJul 2012

StartedJun 2012

CompletionMay 2013

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

210

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach

1 country

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

June 1, 2012

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed

Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

11 months

First QC Date

July 19, 2012

Last Update Submit

May 27, 2013

Conditions

Menorrhagia Metrorrhagia

Keywords

MetrorrhagiaMenorrhagia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Pictorial Blood Assessment Chart (PBAC) score
3 months
Menstrual Cycle Diary
3 months

Study Arms (1)

Women with Heavy Menstrual Bleeding (HMB)

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodProbability Sample

Study Population

Women with heavy menstrual bleeding

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Abbottlead

Study Sites (20)

Site reference ID/Investigator# 79836

Islamabad, Federal Capital, 44000, Pakistan

Location

Site Reference ID/Investigator# 77674

Karachi, Sindh, 74000, Pakistan

Location

Site Reference ID/Investigator# 77675

Karachi, Sindh, 74000, Pakistan

Location

Site reference ID/Investigator# 77676

Karachi, Sindh, 74000, Pakistan

Location

Site Reference ID/Investigator# 77677

Karachi, Sindh, 74000, Pakistan

Location

Site Reference ID/Investigator# 77680

Karachi, Sindh, 74000, Pakistan

Location

Site Reference ID/Investigator# 77681

Karachi, Sindh, 74000, Pakistan

Location

Site reference ID/Investigator # 77690