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Observational Study of Dydrogesterone in Cycle Regularization

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ClinicalTrials.gov Identifier: NCT02029144
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : February 10, 2015
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Zhang Wei, Fudan University

Study Description
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Brief Summary:

Dydrogesterone has been widely used worldwide for various gynecological and obstetric indications:

  • 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.

Condition or disease
Observational Study Dydrogesterone Irregular Menstrual Cycle Abnormal Uterine Bleeding

Detailed Description:
The current study is designed as a prospective, non-interventional, observational study. Patients with irregular cycle diagnosed as AUB-O will be prescribed dydrogesterone as per physician's clinical practice.
Study Design
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Study Type : Observational
Actual Enrollment : 114 participants
Time Perspective: Prospective
Official Title: Dydrogesterone in Cycle Regularization in Abnormal Uterine Bleeding - Ovulation Dysfunction (AUB-O) Patients: A Prospective, Observational Study
Study Start Date : December 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. percentage of patients reporting a regular cycle (defined as cycle duration≥21 and ≤ 35 days) at the end of cycle 3 [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese women who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O
Criteria

Inclusion Criteria:

  • Women aged 16 years or above with menses
  • 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:

  • Hyperprolactinemia and thyroid dysfunction.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029144


Locations
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China, Shanghai
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Fudan University
Abbott
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Zhang Wei, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02029144    
Other Study ID Numbers: A14-390
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Uterine Diseases