Observational Study of Dydrogesterone in Cycle Regularization

Fudan University

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02029144

A14-390

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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