Improving irregular periods in adolescent girls with or without PCOS

Treatment of Menstrual Cycle Alterations in Adolescents

This will try a supplement combining myo‑Inositol and Dioscorea villosa to see if it helps girls aged 14–19 who have irregular or missing periods, including those with PCOS.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 14 Years to 19 Years
• Sex: Female
• Sponsor: Lo.Li.Pharma s.r.l (industry)
• Locations: 3 sites (Tbilisi, Georgia and 2 other locations)
• Trial ID: NCT06800170 on ClinicalTrials.gov

What this trial studies

This interventional program gives adolescent females (14–19 years, at least 3 years after menarche) a combined supplement regimen containing myo‑Inositol, α‑lactalbumin, Dioscorea villosa, and vitamin D to address oligomenorrhea or amenorrhea. Participants with primary amenorrhea, other endocrine disorders, or recent hormonal or relevant supplement use are excluded. The supplements are provided at doses commonly sold commercially and are intended for repeated use over the treatment period. The main outcome is improvement in menstrual cycle regularity in patients with and without PCOS, with visits conducted at participating centers in Georgia, Italy, and Russia.

Who should consider this trial

Good fit: Girls aged 14–19 who are at least three years post‑menarche, have oligomenorrhea or amenorrhea, are not using hormonal therapies or the study supplements, and do not have other endocrine disorders are ideal candidates.

Not a fit: Patients with primary amenorrhea, hyperandrogenism from other causes, hyperprolactinemia, overt hypothyroidism, other hormonal abnormalities, or recent use of hormonal treatments or myo‑Inositol/Dioscorea supplements are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the regimen could help restore more regular menstrual cycles in adolescents and offer a non‑hormonal option for managing cycle irregularities.

How similar studies have performed: Myo‑Inositol has shown benefit for menstrual regularity and metabolic features in adult PCOS in prior studies, but combining it with Dioscorea villosa and testing this approach in adolescents is relatively untested.

Eligibility criteria

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.

Where this trial is running

Tbilisi, Georgia and 2 other locations

• Zhordania and Khomasuridze Institute of Reproductology — Tbilisi, Georgia, Georgia (RECRUITING)
• Agunco — Rome, Italy, Italy (RECRUITING)
• Department of Obstetrics and Gynecology with Reproductive Medicine, F.I. Inozemtsev Academy of Medical Education — Saint Petersburg, Russian Federation, Russia (RECRUITING)

Study contacts

• Study coordinator: Vittorio Unfer

Conditions: Amenorrhea, Oligomenorrhea, PCOS, myo-Inositol, Dioscorea Villosa, adolescents