Observational Study of Dydrogesterone in Cycle Regularization

This study has been completed.
Information provided by (Responsible Party):
Zhang Wei, Fudan University
ClinicalTrials.gov Identifier:
First received: January 6, 2014
Last updated: February 9, 2015
Last verified: February 2015

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.

Observational Study
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 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 ] [ Designated as safety issue: No ]

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.


Ages Eligible for Study:   16 Years and older
Genders 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


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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Please refer to this study by its ClinicalTrials.gov identifier: NCT02029144

China, Shanghai
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Fudan University
  More Information

No publications provided

Responsible Party: Zhang Wei, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT02029144     History of Changes
Other Study ID Numbers: A14-390
Study First Received: January 6, 2014
Last Updated: February 9, 2015
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on October 08, 2015