Treatment of Menstrual Cycle Alterations in Adolescents

NCT06800170 | Recruiting

• 1 other identifier: HP+phD in adolescents
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Amenorrhea; Oligomenorrhea; PCOS (Polycystic Ovary Syndrome)

Keywords

myo-Inositol; Dioscorea Villosa; adolescents

Outcome Measures

Primary Outcomes (1)

• Menstrual cycle regularity

  The intervention is targed to adolescent patients suffering from menstrual cycle alterations. Particularly, we aim to asses the regularization of the menstrual cycle in those patients with polimenhorrea and oligo-/ amenorrhea, with irregular menstrual cycle (shorter than 21 days or longer than 35 days). The purpose of the study is to compare the percentage of patients exhibiting a regular menstrual cycle at the end of the treatment period, in the study group vs control.

  6 months

Study Arms (2)

Treated Group HP+phD

EXPERIMENTAL

Dietary Supplement: myo-Inositol plus DIoscorea Villosa

Controls

NO INTERVENTION

Not treated patients

Interventions

myo-Inositol plus DIoscorea Villosa DIETARY_SUPPLEMENT

myo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily

Also known as: myo-Inositol, Dioscorea Villosa

Treated Group HP+phD

Eligibility Criteria

• Age: 14 Years - 19 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lo.Li.Pharma s.r.l: lead

Study Sites (3)

Zhordania and Khomasuridze Institute of Reproductology

Tbilisi, Georgia, 0112, Georgia

RECRUITING

Agunco

Rome, Italy, 00155, Italy

RECRUITING

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

Saint Petersburg, Russian Federation, Russia

RECRUITING

MeSH Terms

Conditions

Amenorrhea; Oligomenorrhea; Polycystic Ovary Syndrome

Interventions

Inositol

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Central Study Contacts

Vittorio Unfer

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); IT (1); RU (1)