Observational Study of Dydrogesterone in Cycle Regularization

Abnormal Uterine Bleeding Clinical Trial

Official title:

Dydrogesterone in Cycle Regularization in Abnormal Uterine Bleeding - Ovulation Dysfunction (AUB-O) Patients: A Prospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029144
• Other study ID #: A14-390
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: February 9, 2015
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Dydrogesterone
• Irregular Menstrual Cycle
• Observational Study
• Uterine Hemorrhage

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Abbott

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients reporting a regular cycle (defined as cycle duration=21 and = 35 days) at the end of cycle 3		12 months	No