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

Lo.Li.Pharma

Status

Enrolling

Conditions

Amenorrhea

Oligomenorrhea

PCOS (Polycystic Ovary Syndrome)

Treatments

Dietary Supplement: myo-Inositol plus DIoscorea Villosa

Study type

Interventional

Funder types

Industry

Identifiers

NCT06800170

HP+phD in adolescents

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

14 to 19 years old

Volunteers

No 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.