Observational Study of Dydrogesterone in Cycle Regularization

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02029144

Enrollment

114

Registered

2014-01-07

Start date

2013-12-31

Completion date

2015-02-28

Last updated

2015-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Uterine Bleeding, Dydrogesterone, Irregular Menstrual Cycle, Observational Study

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to No maximum

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

Design outcomes

Primary

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

Countries

China

Outcome results