OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

PCOS Clinical Trial

Official title:

Doppler Analysis of Ovarian Stromal Blood Flow Changes After Treatment With Metformin Versus Ethinylestradiol-cyproterone Acetate in Women With Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236740
• Other study ID #: OG/2017/12
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2017
• Last updated: March 17, 2018
• Start date: August 1, 2017
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2018
• Source: S.C.B. Medical College and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 15, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Women diagnosed with PCOS according to the Rotterdam criteria

Exclusion Criteria:

• Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.

• Medical or surgical treatment of PCOS during the previous 3 months

• Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone

• Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)

• Inability to understand the proposal of the study precluding effective informed consent

Related Conditions & MeSH terms

• PCOS

Intervention

Drug:
• Ethinyl Estradiol-cyprosterone acetate
Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.
• Metformin Hydrochloride
Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.

Locations

Country	Name	City	State
India	SCB Medical College	Cuttack	Orissa

Sponsors (1)

Lead Sponsor	Collaborator
S.C.B. Medical College and Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in ovarian stromal blood flow by using Doppler	By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination.	6 months
Secondary	Change in BMI as measured in kg/m2		6 months
Secondary	Improvement in hirsutism measured by Modified Ferriman and Gallwey scores		6 months
Secondary	Improvement in menstrual cycle pattern		6 months
Secondary	Change in waist circumference (cm)		6 months
Secondary	Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml)		6 months
Secondary	Change in blood level of Testosterone (nmol/L)		6 months
Secondary	Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml)		6 months
Secondary	Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl)		6 months
Secondary	Changes in fasting serum insulin levels (mIU/L)		6 months
Secondary	Changes in fasting serum glucose levels (mg/dL)		6 months
Secondary	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)		6 months