Treatment of Menstrual Cycle Alterations in Adolescents (HP-phD_Adolesc)

January 5, 2026 updated by: Vittorio Unfer, Lo.Li.Pharma s.r.l
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Georgia
    • Georgia
      • Tbilisi, Georgia, Georgia, 0112
        • Recruiting
        • Zhordania and Khomasuridze Institute of Reproductology
        • Contact:
  • Italy
    • Italy
      • Rome, Italy, Italy, 00155
        • Recruiting
        • Agunco
        • Contact:
  • Russia
    • Russian Federation
      • Saint Petersburg, Russian Federation, Russia
        • Recruiting
        • Department of Obstetrics and Gynecology with Reproductive Medicine, F.I. Inozemtsev Academy of Medical Education
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated Group HP+phD
Dietary supplement: myo-Inositol plus DIoscorea Villosa
myo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily
Other Names:
  • myo-Inositol
  • Dioscorea Villosa
No Intervention: Controls
Not treated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual cycle regularity
Time Frame: 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP+phD in adolescents

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amenorrhea

Clinical Trials on myo-Inositol plus DIoscorea Villosa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe