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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with Heavy Menstrual Bleeding (HMB) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pictorial Blood Assessment Chart (PBAC) score | 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 |
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Inclusion Criteria
Exclusion Criteria
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Women with heavy menstrual bleeding
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| Name | Affiliation | Role |
|---|---|---|
| Raeef Ahmed, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site reference ID/Investigator# 79836 | Islamabad, Federal Capital | 44000 | Pakistan | |||
| Site Reference ID/Investigator# 77674 |
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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 |
| Karachi, Sindh |
| 74000 |
| Pakistan |
| Site Reference ID/Investigator# 77675 | Karachi, Sindh | 74000 | Pakistan |
| Site reference ID/Investigator# 77676 | Karachi, Sindh | 74000 | Pakistan |
| Site Reference ID/Investigator# 77677 | Karachi, Sindh | 74000 | Pakistan |
| Site Reference ID/Investigator# 77680 | Karachi, Sindh | 74000 | Pakistan |
| Site Reference ID/Investigator# 77681 | Karachi, Sindh | 74000 | Pakistan |
| Site reference ID/Investigator # 77690 | Lahore, Punjab | 54000 | Pakistan |
| Site Reference ID/Investigator# 77691 | Lahore, Punjab | 54000 | Pakistan |
| Site reference ID/Investigator# 77694 | Lahore, Punjab | 54000 | Pakistan |
| Site Reference ID/Investigator# 77695 | Lahore, Punjab | 54000 | Pakistan |
| Site Reference ID/Investigator# 77696 | Lahore, Punjab | 54000 | Pakistan |
| Site reference ID/Investigator# 77698 | Lahore, Punjab | 54000 | Pakistan |
| Site Reference ID/Investigator# 77699 | Lahore, Punjab | 54000 | Pakistan |
| Site Reference ID/Investigator# 77686 | Multan, Punjab | 60000 | Pakistan |
| Site Reference ID/Investigator# 77687 | Multan, Punjab | 60000 | Pakistan |
| Site Reference ID/Investigator# 77684 | Multan, Punjab | 6000 | Pakistan |
| Site Reference ID/Investigator# 77689 | Multan, Punjab | 6000 | Pakistan |
| Site reference ID/Investigator # 77693 | Rawalpindi, Punjab | 46000 | Pakistan |
| Site reference ID/Investigator# 79834 | Rawalpindi, Punjab | 46000 | Pakistan |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
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