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Treatment of Menstrual Cycle Alterations in Adolescents | Clinical Trials | Clareo Health

RECRUITINGNA

Treatment of Menstrual Cycle Alterations in Adolescents

NCT06800170•Lo.Li.Pharma s.r.l

Summary

the aim of the present study is intended to evaluate how treatment with Myo-Inositol and Dioscorea Villosa can help improve menstrual cycle irregularities in adolescents, both with and without PCOS.

Detailed Description

The present study aims to evaluate the possible beneficial effect of a treatment with Inofolic HP combined with Inofolic phD on the improvement if menstrual cycle alteration in adolescent patients with or without PCOS. The molecules chosen for the study are the following: myo-Inositol, α-lactalbumin, Dioscorea Villosa, and Vitamin D, are already commercialized as dietary supplements, commonly administered at same dosage provided in the present study, also for prolonged treatments, with no side effects associated.

Eligibility

Age

14 - 19 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•adolescent women aged 14-19 years old, with at least 3 years passed after menarche, and oligomenorrhea or amenorrhea

Exclusion Criteria

•Primary amenorrhea.
•Hyperandrogenism due to other factors (i.e. adrenal hyperplasia or Cushing syndrome).
•Hyperprolactinemia or overt hypothyroidism (TSH ≥4).
•Other hormonal alterations.
•Ongoing hormonal therapies, including OCPs, six months before enrollment.
•Ongoing pharmacological therapies.
•Ongoing use of myo-Inositol supplement or other source of myo-Inositol, or Dioscorea villosa, six months before enrollment.

Locations (3)

Zhordania and Khomasuridze Institute of Reproductology

Tbilisi, Georgia, Georgia

Agunco

Rome, Italy, Italy

Department of Obstetrics and Gynecology with Reproductive Medicine, F.I. Inozemtsev Academy of Medical Education

Saint Petersburg, Russian Federation, Russia

Key Dates

Start Date

June 1, 2025

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

January 6, 2026

Enrollment

ESTIMATED participants

Conditions

AmenorrheaOligomenorrheaPCOS (Polycystic Ovary Syndrome)

Interventions

myo-Inositol plus DIoscorea Villosa

DIETARY_SUPPLEMENT

Contacts

Vittorio Unfer

CONTACT

(+39)06/22442074 vunfer@gmail.com

Pro- and Anti-inflammatory Cytokines in PCOS

NCT06793085

Reproductive AgePCOS (Polycystic Ovary Syndrome)

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RECRUITING

Functional Proteins in Polycystic Ovary Syndrome

NCT06793098

Reproductive AgePCOS (Polycystic Ovary Syndrome)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment of Menstrual Cycle Alterations in Adolescents

Inclusion Criteria

Exclusion Criteria

Pro- and Anti-inflammatory Cytokines in PCOS

Functional Proteins in Polycystic Ovary Syndrome

Role of Estrogen on Skeletal Outcomes in FHA

Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)

Assessment of Nutritional Knowledge, Habits, and Eating Behavior in Athletic Women to Evaluate the Possible Impact on Their Menstrual Function

Letrozole 5 mg for 10 Days Versus Letrozole 10 mg for 5 Days for Ovarian Stimulation in PCOS