The Effect of Metformin on Different Hormones in PCOS Patients

NCT02568488 | Completed Phase 4 DMC

• 1 other identifier: 138
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:

1. 1.history of chronic anovulation defined as cycle length \> 35 days, or less than 9 cycles per year or amenorrhoea (cycle length \> 12wks),
2. 2.infertility with hirsutism or acne or elevation of one or more of serum androgen levels
3. 3.ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).

Conditions

Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (1)

• hormonal changes

  total and free testosterone

  Change from Baseline at 3 and 6 months

Secondary Outcomes (5)

• serum insulin levels

  Change from Baseline at 3 and 6 months

• ovarian morphology

  Change from Baseline at 3 and 6 months

• sex hormone binding globulin (SHBG)

  Change from Baseline at 3 and 6 months

• Antimullerian Hormone (AMH)

  Change from Baseline at 3 and 6 months

• Dihydroepiandrostenedione sulphate (DHEAS)

  Change from Baseline at 3 and 6 months

Study Arms (1)

metformin

EXPERIMENTAL

PCOS women receiving metformin 850 mg orally twice daily over a period of 6 months

Drug: Metformin

Interventions

Metformin DRUG

850 mg orally twice daily for 6 months

Also known as: glucophage

metformin

Eligibility Criteria

• Age: 18 Years - 33 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non pregnant PCOS patients .
• The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:
• history of chronic anovulation defined as cycle length \> 35 days, or less than 9 cycles per year or amenorrhoea (cycle length \> 12wks),
• infertility with hirsutism or acne or elevation of one or more of serum androgen levels
• ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).

You may not qualify if:

• those with prior history of glucose intolerance,
• history of gestational diabetes,
• NIDDM patients,
• cushing's syndrome,
• thyroid dysfunction,
• hyperprolactinemia,
• congenital adrenal hyperplasia
• patients on prolonged corticosteroid course, or other medications that alter the hormonal or metabolic profile; including PCOS patients who were on OCPs or cyclic progestagens

Sponsors & Collaborators

• Ahmed Maged: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 6, 2015
• Study Start: March 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 21, 2017

Record last verified: 2017-03