CompletedNot Applicable

Observational Study of Dydrogesterone in Cycle Regularization

China114 participantsStarted 2013-12

Plain-language 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.

Who can participate

Age range

16 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT02029144

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-02

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