Observational Study of Dydrogesterone in Cycle Regularization

Completed

• Conditions: Dydrogesterone; Abnormal Uterine Bleeding; Observational Study; Irregular Menstrual Cycle

• Registration Number: NCT02029144
• Lead Sponsor: Fudan University

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.

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of patients reporting a regular cycle (defined as cycle duration≥21 and ≤ 35 days) at the end of cycle 3	12 months

Trial Locations

Locations (1)

Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China