Status:
COMPLETED
Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study
Lead Sponsor:
Abbott
Conditions:
Irregular Menstrual Cycle
Eligibility:
FEMALE
18-75 years
Brief Summary
In India Duphaston is approved and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunction...
Detailed Description
Primary objective: • To determine percentage of patients reporting a regular cycle (defined as cycle duration between 21 to 35 days, inclusive) at the end of treatment period. Secondary objectives: ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Women aged 18 years or older
- Suffering from irregular menstrual cycle for at least 3 months and for whom the physician decides to prescribe Duphaston, in accordance with locally approved package insert
- Patients willing to sign written authorization to provide data for the study
- Exclusion Criteria
- Patients having known hypersensitivity to the active ingredient or excipients
- Patients having known or suspected progesterone-dependent neoplasms
- Patients having vaginal bleeding of unknown etiology
- Patients taking oral contraceptives
- Pregnant and lactating patients
- Any other condition that precludes use of Duphaston in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with history of liver disease, porphyria or depression)
- Patients not willing to sign written authorization for data release consent form
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01525563
Start Date
April 1 2012
End Date
December 1 2013
Last Update
December 29 2014
Active Locations (32)
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1
Site Reference ID/Investigator# 69002
Ahmedabad, India, 380015
2
Site Reference ID/Investigator# 68995
Ahmedabad, India, 380051
3
Site Reference ID/Investigator# 68991
Ahmedabad, India, 390015
4
Site Reference ID/Investigator# 68990
Bangalore, India, 560005