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

Completed

• Conditions: Menorrhagia; Metrorrhagia

• Registration Number: NCT01647360
• Lead Sponsor: Abbott

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 available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-23
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-27
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EQ-5D Quality of Life questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Pictorial Blood Assessment Chart (PBAC) score	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.
Menstrual Cycle Diary	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.

Trial Locations

Locations (20)

Site reference ID/Investigator# 79836; 🇵🇰 Islamabad, Federal Capital, Pakistan

Site Reference ID/Investigator# 77674; 🇵🇰 Karachi, Sindh, Pakistan

Site Reference ID/Investigator# 77675; 🇵🇰 Karachi, Sindh, Pakistan

Site Reference ID/Investigator# 77677; 🇵🇰 Karachi, Sindh, Pakistan

Site Reference ID/Investigator# 77680; 🇵🇰 Karachi, Sindh, Pakistan

Site Reference ID/Investigator# 77681; 🇵🇰 Karachi, Sindh, Pakistan

Site Reference ID/Investigator# 77691; 🇵🇰 Lahore, Punjab, Pakistan

Site reference ID/Investigator# 77694; 🇵🇰 Lahore, Punjab, Pakistan

Site Reference ID/Investigator# 77695; 🇵🇰 Lahore, Punjab, Pakistan

Site Reference ID/Investigator# 77696; 🇵🇰 Lahore, Punjab, Pakistan

Site reference ID/Investigator# 77698; 🇵🇰 Lahore, Punjab, Pakistan

Site Reference ID/Investigator# 77699; 🇵🇰 Lahore, Punjab, Pakistan

Site Reference ID/Investigator# 77687; 🇵🇰 Multan, Punjab, Pakistan

Site Reference ID/Investigator# 77684; 🇵🇰 Multan, Punjab, Pakistan

Site Reference ID/Investigator# 77689; 🇵🇰 Multan, Punjab, Pakistan

Site reference ID/Investigator # 77693; 🇵🇰 Rawalpindi, Punjab, Pakistan

Site reference ID/Investigator# 79834; 🇵🇰 Rawalpindi, Punjab, Pakistan

Site reference ID/Investigator# 77676; 🇵🇰 Karachi, Sindh, Pakistan

Site reference ID/Investigator # 77690; 🇵🇰 Lahore, Punjab, Pakistan

Site Reference ID/Investigator# 77686; 🇵🇰 Multan, Punjab, Pakistan