Health TrialsbyHealthPanel

The Combined Effect of N-Acetyl Cysteine and Metformin in Polycystic Ovary Syndrome Patients

ConditionPolycystic Ovary Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorCairo University

About this trial

The study aims to evaluate the effects of combination of metformin with NAC in PCOS on biochemical and hormonal parameters.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged 20 to 45 years old.

Confirmed diagnosis with PCOS according to the 2023 International Evidence-based Guideline for the Assessment and Management of PCOS.

Ability to give informed consent.

Disqualifiers

Hypersensitivity to either metformin or NAC.

Consumption of medications affecting carbohydrate metabolism, such as insulin, sulfonylureas, and taking hormonal analogues two months prior to enrollment.

Hyperprolactinemia, defined as a prolactin level above laboratory reference range.

Diabetes mellitus.

Trial design

Design model

Parallel

Treatments tested in this trial

  • N-acetyl cysteine

    Drug

    N-Acetyl Cysteine (NAC) has antioxidant properties and is essential for the body's production of glutathione, and both glutathione and NAC are potent antioxidants.

  • Metfomin

    Drug

    metformin is commonly used for managing polycystic ovary syndrome (PCOS) due to its benefits in addressing several underlying features of the condition. While it is not officially approved by regulatory agencies like the FDA for PCOS, it is widely recognized and recommended in clinical practice guidelines as an off-label treatment for PCOS, particularly in women with insulin resistance and metabolic dysfunction.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Group-MNExperimental treatment 2 interventions
Group B: Group-MExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary outcome will be change in LH/FSH levels.

change in LH/FSH ratio

Time frame
3 months

Secondary outcomes

1

improvement in hormonal levels in patients with PCOS

Hormonal profile change in: Total testosterone levels (ng/dL) Free testosterone levels (ng/dL) Free testosterone to total testosterone (FT/TT) ratio, calculated from the measured values.

Time frame
3 months
2

improvement in clinical features in patients with PCOS

improvement in clinical features: Menstrual irregularities: improvement in oligomenorrhea or amenorrhea, assessed based on The 2023 International Evidence-based Guideline for the Assessment and Management of PCOS Hirsutism: Assessed using the modified Ferriman-Gallwey (mFG) score Acne: Evaluated using the Investigator Global Assessment (IGA) scale technique.

Time frame
3 months
3

improvement in biochemical parameters in patients with PCOS

biochemical parameters change in: Fasting insulin levels (µIU/mL). Fasting blood glucose (FBG) levels (mg/dL). Glucose/insulin ratio, calculated using fasting glucose and insulin levels. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated using the standard formula.

Time frame
3 months
4

improvement in metabolic parameters in patients with PCOS

weight in kilograms, height in meters Body mass index (BMI) (kg/m2), calculated as weight (kg) divided by height (m2).

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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