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Completed

NCT Number: NCT02029144

Observational Study of Dydrogesterone in Cycle Regularization

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.

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Key information

Conditions

Observational Study Abnormal Uterine Bleeding Dydrogesterone Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Irregular Menstrual Cycle Menstruation Disturbances Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2014
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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