Observational Study of Dydrogesterone in Cycle Regularization
Verified November 2013 by Fudan University
Information provided by (Responsible Party):
Zhang Wei, Fudan University
First received: January 6, 2014
Last updated: NA
Last verified: November 2013
History: No changes posted
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.
Irregular Menstrual Cycle
Abnormal Uterine Bleeding
||Time Perspective: Prospective
||Dydrogesterone in Cycle Regularization in Abnormal Uterine Bleeding - Ovulation Dysfunction (AUB-O) Patients: A Prospective, Observational Study
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Chinese women who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02029144
|Obstetrics and Gynecology Hospital of Fudan University
|Shanghai, Shanghai, China, 200011 |
|Contact: Wei Zhang, PhD +86 13611691036 firstname.lastname@example.org |
No publications provided
||Zhang Wei, Professor, Fudan University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 6, 2014
||January 6, 2014
||China: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs