Observational Study of Dydrogesterone in Cycle Regularization

NCT02029144 | Completed

• 1 other identifier: A14-390
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• percentage of patients reporting a regular cycle (defined as cycle duration≥21 and ≤ 35 days) at the end of cycle 3

  12 months

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese women who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• Abbott: collaborator

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Menstruation Disturbances; Metrorrhagia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

CN (1)