Observational Study of Dydrogesterone in Cycle Regularization

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Fudan University
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Zhang Wei, Fudan University
ClinicalTrials.gov Identifier:
NCT02029144
First received: January 6, 2014
Last updated: NA
Last verified: November 2013
History: No changes posted
  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 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 ]

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: November 2014 (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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China, Shanghai
Obstetrics and Gynecology Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200011
Contact: Wei Zhang, PhD    +86 13611691036    zhangwei623@hotmail.com   
Sponsors and Collaborators
Fudan University
Abbott
  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: January 6, 2014
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2014