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Observational Study of Dydrogesterone in Cycle Regularization

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02029144
First Posted: January 7, 2014
Last Update Posted: February 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Zhang Wei, Fudan University
  Purpose

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
Observational Study Dydrogesterone Irregular Menstrual Cycle Abnormal Uterine Bleeding

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Dydrogesterone in Cycle Regularization in Abnormal Uterine Bleeding - Ovulation Dysfunction (AUB-O) Patients: A Prospective, Observational Study

Resource links provided by NLM:


Further study details as provided by Zhang Wei, Fudan University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 114
Study Start Date: December 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
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
China, Shanghai
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Fudan University
Abbott
  More Information

Responsible Party: Zhang Wei, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02029144     History of Changes
Other Study ID Numbers: A14-390
First Submitted: January 6, 2014
First Posted: January 7, 2014
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs