D-chiro-inositol and AUB

University Of Perugia

Status and phase: Not yet enrolling; Phase 2

Conditions: Abnormal Uterine Bleeding

Treatments: Dietary Supplement: D-chiro-inositol and lactalbumin (low dose); Dietary Supplement: D-chiro-inositol and lactalbumin (high dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT06398145

INOSENDO

Details and patient eligibility

About

Patients with AUB will undergo 6-month treatment with D-chiro-inositol and will fill in questionnaires on AUB, with the evaluation of hormonal serum levels.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AUB

Exclusion criteria

• Menopause
• Cancer diagnosis
• Atypical endometrial hyperplasia
• Uterine fibroids
• Heavy symptoms requiring pharmacological intervention
• Progestogens treatment in the six months before the study
• Inositol treatment in the six months before the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Treatment

Experimental group

Description:

Patients will undergo 3 months treatment with 1200 mg D-chiro-inositol and 120 mg lactalbumin, than 3 months treatment with 600 mg D-chiro-inositol and 60 mg lactalbumin

Treatment:

Dietary Supplement: D-chiro-inositol and lactalbumin (high dose)

Dietary Supplement: D-chiro-inositol and lactalbumin (low dose)