Trial Outcomes & Findings for Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome (NCT NCT03117517)

NCT ID: NCT03117517

Last Updated: 2020-03-02

Results Overview

IL-6 and IL-8 levels by ELISA method using commercially available kits.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 106 participants
• Primary outcome timeframe: Baseline and after 3 Months
• Results posted on: 2020-03-02

Participant Flow

Participant milestones

Measure	Metformin Drug intervention: Metformin 500 mg tablet twice orally for 3 months Metformin: Metformin (1000 mg)	Metformin, Pioglitazone Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)
Overall Study STARTED	53	53
Overall Study COMPLETED	48	49
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metformin n=53 Participants Drug intervention: Metformin 500 mg tablet twice orally for 3 months Metformin: Metformin (1000 mg)	Metformin, Pioglitazone n=53 Participants Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)	Total n=106 Participants Total of all reporting groups
Age, Continuous	25.63 Years STANDARD_DEVIATION 4.55 • n=53 Participants	25.44 Years STANDARD_DEVIATION 3.74 • n=53 Participants	25.53 Years STANDARD_DEVIATION 6.42 • n=106 Participants
Sex: Female, Male Female	53 Participants n=53 Participants	53 Participants n=53 Participants	106 Participants n=106 Participants
Sex: Female, Male Male	0 Participants n=53 Participants	0 Participants n=53 Participants	0 Participants n=106 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Pakistan	53 Participants n=53 Participants • Participants drop-out in follow-up.	53 Participants n=53 Participants • Participants drop-out in follow-up.	106 Participants n=106 Participants • Participants drop-out in follow-up.

PRIMARY outcome

Timeframe: Baseline and after 3 Months

Population: Measurement of IL-6 levels in serum samples at baseline and after 3 months of treatment

IL-6 and IL-8 levels by ELISA method using commercially available kits.

Outcome measures

Measure	Metformin n=53 Participants Drug intervention: Metformin 500 mg tablet twice orally for 3 months Metformin: Metformin (1000 mg)	Metformin, Pioglitazone n=53 Participants Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)
Cytokines and Chemokines Measurements IL-6 levels at baseline	14.60 pg/ml Interval 12.05 to 17.69	14.12 pg/ml Interval 11.58 to 17.23
Cytokines and Chemokines Measurements IL-6 levels after 3 months of treatment	12.65 pg/ml Interval 10.61 to 15.08	11.12 pg/ml Interval 10.02 to 12.33
Cytokines and Chemokines Measurements IL-8 Llevels at baseline	61.92 pg/ml Interval 52.95 to 72.41	41.86 pg/ml Interval 38.24 to 45.83
Cytokines and Chemokines Measurements IL-8 Llevels after treatment	32.70 pg/ml Interval 22.99 to 46.5	22.00 pg/ml Interval 16.76 to 28.88

SECONDARY outcome

Timeframe: Baseine and after 3 Months

Population: Serum LH level at basline

Serum level of LH was measure at baseline and after 3 months of treatment

Outcome measures

Measure	Metformin n=53 Participants Drug intervention: Metformin 500 mg tablet twice orally for 3 months Metformin: Metformin (1000 mg)	Metformin, Pioglitazone n=53 Participants Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)
Hormonal Profiles LH level at baseline	5.79 mIU/ml Interval 4.95 to 6.77	6.625 mIU/ml Interval 5.52 to 7.94
Hormonal Profiles LH level after treatment	4.92 mIU/ml Interval 4.33 to 5.59	5.16 mIU/ml Interval 4.5 to 5.91

SECONDARY outcome

Timeframe: Baseline and after 3 months

Population: Insulin resistance was determined by HOMA-IR

Insulin resistance was measure by calculating HOMA-IR from the data of insulin and sugar levels.

Outcome measures

Measure	Metformin n=53 Participants Drug intervention: Metformin 500 mg tablet twice orally for 3 months Metformin: Metformin (1000 mg)	Metformin, Pioglitazone n=53 Participants Drugs intervention: Combination of Metformin (1000 mg) and pioglitazone (30 mg) tablets will be given orally for 3 months Metformin, Pioglitazone: Metformin (1000 mg) Pioglitazone (30 mg)
Insulin Resistance HOMA-IR at baseline	7.19 unitless Standard Deviation 3.00	6.22 unitless Standard Deviation 2.65
Insulin Resistance HOMA-IR after treatment	3.97 unitless Standard Deviation 2.03	3.84 unitless Standard Deviation 2.13

Adverse Events

Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metformin, Pioglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohsin Shah (Associate Professor)

Khyber Medical University

Phone: 3429620074

Email: mohsin.ibms@kmu.edu.pk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place