Observational Study of Dydrogesterone in Cycle Regularization
NCT ID: NCT02029144
Last Updated: 2015-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
114 participants
OBSERVATIONAL
2013-12-31
2015-02-28
Brief Summary
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* Dydrogesterone is effective in cycle regulation treatment.
* Dydrogesterone is recognized as none interference to hypothalamus pituitary ovary (HPO) axis in the recommended dosage.
* Dydrogesterone might have non-negative effect on glucose and lipid metabolic.
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O (irregular cycle is defined as cycle duration \< 21days or \>35 days)
* Physicians have decided to prescribe dydrogesterone 10mg for cycle regulation treatment, orally taking dydrogesterone 10mg twice daily, from day16 to day 25 of each cycle, being consecutive at least 3 cycles
* Patient who is willing to sign written authorization
Exclusion Criteria
* Patient took cycle regulation treatment including oral contraceptives, sex hormone or glucocorticoid in the past 1 month
* Women with estrogen deficiency related symptom
* Patient who meets the contraindications listed in Chinese label of dydrogesterone
* Pregnant and lactating patients
* Patient who is not suitable for the study according to physician's discretion
16 Years
FEMALE
No
Sponsors
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Abbott
INDUSTRY
Fudan University
OTHER
Responsible Party
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Zhang Wei
Professor
Locations
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Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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A14-390
Identifier Type: -
Identifier Source: org_study_id
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