Treatment of Menstrual Cycle Alterations in Adolescents
NCT ID: NCT06800170
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-06-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treated Group HP+phD
myo-Inositol plus DIoscorea Villosa
myo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily
Controls
Not treated patients
No interventions assigned to this group
Interventions
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myo-Inositol plus DIoscorea Villosa
myo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
14 Years
19 Years
FEMALE
No
Sponsors
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Lo.Li.Pharma s.r.l
INDUSTRY
Responsible Party
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Vittorio Unfer
Professor
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HP+phD in adolescents
Identifier Type: -
Identifier Source: org_study_id
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