Observational StudyNCT02029144
Observational Study of Dydrogesterone in Cycle Regularization
An observational study of Observational Study and Dydrogesterone, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Observational Study, Dydrogesterone, Irregular Menstrual Cycle
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese women who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Dydrogesterone in Cycle Regularization in Abnormal Uterine Bleeding - Ovulation Dysfunction (AUB-O) Patients: A Prospective, Observational Study
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.
Read the 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.
- Medical subject headings
- Menstruation Disturbances, Metrorrhagia
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients reporting a regular cycle (defined as cycle duration≥21 and ≤ 35 days) at the end of cycle 3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observational StudyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Zhang Wei, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029144
- Sponsor's protocol ID
- A14-390
- Status last verified
- Feb 2015
- First submitted
- 6 Jan 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dydrogesterone in Cycle Regularization in Abnormal Uterine Bleeding - Ovulation Dysfunction (AUB-O) Patients: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT02029144
- Acronym / sponsor ID
- A14-390
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese women who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational Study and Dydrogesterone, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.