Extended-release vs Immediate-release Metformin in PCOS W... | NCT02984722

Studies
Extended-release vs Immediate-release Metformin in PCOS Women

NCT02984722

Sponsor

Catholic University of the Sacred Heart

Status

Unknown status

Last Update Posted

Dec 7, 2016Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Countries

Italy

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Dec 3, 2016

First Submission Date that Met QC Criteria

Dec 6, 2016

First Posted Date

Dec 7, 2016Estimated

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

Dec 6, 2016

Last Update Posted Date

Dec 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rosanna Apa, Professor, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Description Module

Brief Summary

The aim of our study is to compare the different effects of 6 months treatment with extended-release metformin and immediate-release metformin on clinical, endocrine and metabolic parameters in women affected by polycystic ovary syndrome. We also evaluate gastrointestinal disorders associated with the two different compouds.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	PCOS women treated with 1500 mg/die of extended-release metformin	Drug: Metformin
2	Experimental	PCOS women treated with 1500 mg/die of immediate-release metformin	Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug		1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastro intestinal disorders		6 months

Secondary Outcomes

Measure	Description	Time Frame
number of cycles in 6 months of therapy		6 months
insulin levels		6 months
hirsutism score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

pregnancy
diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
past history of cardiovascular diseases
past history of gastro-intestinal diseases
significant liver or renal dysfunction (hypothalamic, pituitary, thiroidal or adrenal);
neoplasms.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic university of Sacred Heart		Rome	Rome	00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided