Observational Study of Dydrogesterone in Cycle Regulariza... | NCT02029144

Studies
Observational Study of Dydrogesterone in Cycle Regularization

NCT02029144

Sponsor

Fudan University

Status

Completed

Last Update Posted

Feb 10, 2015Estimated

Enrollment

114Actual

Phase

Not provided

Conditions

Observational Study
Dydrogesterone
Irregular Menstrual Cycle
Abnormal Uterine Bleeding

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jan 6, 2014

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2015

Last Update Posted Date

Feb 10, 2015Estimated

Name	Class
Abbott	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of patients reporting a regular cycle (defined as cycle duration≥21 and ≤ 35 days) at the end of cycle 3		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Obstetrics and Gynecology Hospital of Fudan University		Shanghai	Shanghai Municipality	200011	China

Condition Browse Module

MeSH Terms

ID	Term
D008599	Menstruation Disturbances
D008796	Metrorrhagia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014592	Uterine Hemorrhage
D014591	Uterine Diseases

Browse Leaves

Not provided

Browse Branches

Not provided