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Completed

NCT Number: NCT03673995

Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS

PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hair Diseases Hirsutism Menstrual Problem Menstruation Disturbances Neoplasms Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Virilism

Age range

16 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Altamedica Reproductive Medicine

Roma, 00198, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

° PCOS patients

Exclusion criteria

  • thyroid dysfunction
  • hyperprolactinemia
  • adrenal hyperplasia
  • patients taking oral contraceptive
  • any other endocrinological pathologies

Treatment and study plan

Myo-inositol+L-tyrosine

Dietary Supplement

PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment.

Primary outcomes

  1. Restore of regular menstrual period

    Time frame: 6 months of treatment

    Self report

Secondary outcomes

  1. Improving hirsutism

    Time frame: 6 months of treatment

    Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism,

  2. Restore ovulation

    Time frame: 6 months of treatment

    Progesterone value in luteal phase

Sponsors and collaborators

Lead sponsor

Pharmarte srl

Industry

Registry information

Official study title

Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 17, 2018
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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