Clinical trial NCT01647360: Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menorrhagia
Metrorrhagia
Keywords: Metrorrhagia
Menorrhagia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2012-07-23
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with heavy menstrual bleeding

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.


Eligibility 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)

Primary outcomes:
measure: EQ-5D Quality of Life questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Pictorial Blood Assessment Chart (PBAC) score
timeFrame: 3 months
measure: Menstrual Cycle Diary
timeFrame: 3 months
Other outcomes:
Locations:
city: Islamabad, Federal Capital
country: Pakistan
facility: Site reference ID/Investigator# 79836
city: Karachi, Sindh
country: Pakistan
facility: Site Reference ID/Investigator# 77674
city: Karachi, Sindh
country: Pakistan
facility: Site Reference ID/Investigator# 77675
city: Karachi, Sindh
country: Pakistan
facility: Site reference ID/Investigator# 77676
city: Karachi, Sindh
country: Pakistan
facility: Site Reference ID/Investigator# 77677
city: Karachi, Sindh
country: Pakistan
facility: Site Reference ID/Investigator# 77680
city: Karachi, Sindh
country: Pakistan
facility: Site Reference ID/Investigator# 77681
city: Lahore, Punjab
country: Pakistan
facility: Site reference ID/Investigator # 77690
city: Lahore, Punjab
country: Pakistan
facility: Site Reference ID/Investigator# 77691
city: Lahore, Punjab
country: Pakistan
facility: Site reference ID/Investigator# 77694
city: Lahore, Punjab
country: Pakistan
facility: Site Reference ID/Investigator# 77695
city: Lahore, Punjab
country: Pakistan
facility: Site Reference ID/Investigator# 77696
city: Lahore, Punjab
country: Pakistan
facility: Site reference ID/Investigator# 77698
city: Lahore, Punjab
country: Pakistan
facility: Site Reference ID/Investigator# 77699
city: Multan, Punjab
country: Pakistan
facility: Site Reference ID/Investigator# 77686
city: Multan, Punjab
country: Pakistan
facility: Site Reference ID/Investigator# 77687
city: Multan, Punjab
country: Pakistan
facility: Site Reference ID/Investigator# 77684
city: Multan, Punjab
country: Pakistan
facility: Site Reference ID/Investigator# 77689
city: Rawalpindi, Punjab
country: Pakistan
facility: Site reference ID/Investigator # 77693
city: Rawalpindi, Punjab
country: Pakistan
facility: Site reference ID/Investigator# 79834
Study officials:
affiliation: Abbott
name: Raeef Ahmed, MD
role: STUDY_DIRECTOR
References: