Comparison of the effect of medroxyprogesterone acetate and black seed extract on the symptoms of polycystic ovary syndrome in adolescent girls

Phase 1

Recruiting

• Conditions: Polycystic ovary syndrome.; Polycystic ovarian syndrome; E28.2

• Registration Number: IRCT20221017056209N1
• Lead Sponsor: Gonabad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 116

Inclusion Criteria

Age range 12-18 years
2 years have passed since the start of menstruation
Having the written consent of the teenager and her parents to participate in the study
Ultrasound-confirmed polycystic ovary according to the Amsterdam criteria
Absence of other causes of hyperandrogenism such as non-classical congenital adrenal hyperplasia, Cushing's syndrome (based on clinical history and participant's symptoms and statements), body mass index 25-19
Not using hormonal drugs in the last three months
Not taking drugs that interact with medroxyprogesterone acetate, including amphetamine, thyroid drugs, diphenhydramine, ciprofloxacin, clofin, duloxetine, estradiol, omega-3 saturated fatty acids, lesilalopram, pregabalin, levonorgestrel, montelukast, levothyroxine, testosterone, cyanocobalamin. , ascorbic acid, colcalcinol, multivitamin, sertraline, cetirizine
Insensitivity to black seed and medroxyprogesterone (according to the comment of the participant)
Not suffering from diseases such as hypothyroidism, hyperprolactinemia with kidney, heart, liver, bone diseases, pituitary tumor, cancer and diabetes (based on clinical history and participants' statements)
Not using tobacco and drugs (based on the participants' statements)
No history of surgery on one or both ovaries
There is no history of stressful events in the last three months (such as the death of a family member, accident, sexual violence, robbery) according to the teenager's self-report and parents' statements.

Exclusion Criteria

Unwillingness to participate in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of polycystic ovary syndrome symptoms. Timepoint: The beginning of the study (before the intervention), 16 weeks after the intervention. Method of measurement: Ovarian volume ultrasound, LH test, GTT 1hr, GTT 2hr, total testosterone, fasting blood sugar, dihydroepiandrosterone sulfate or DHEA-S and androgen levels (testosterone and dihydroepiandrosterone sulfate or DHEA-S).