Diamel in the Treatment of Polycystic Ovary Syndrome

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome

Treatments: Dietary Supplement: Diamel; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01051024

CAT-0917-CU

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.

Enrollment: 110 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Two of the following criteria:

  • Oligo or Anovulation
  • Polycystic Ovary diagnosed by ultrasound technique
  • Clinical signs of Hyperandrogenism

• Signed informed consent

Exclusion criteria

• Personal history of other causes of hyperandrogenism: Hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism.
• Patients under other experimental treatment
• Treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment
• Treatment with vitamins within 7 days before treatment
• Treatment with dietary supplements within 60 days before treatment
• Non-compensated intercurrent diseases: diabetes mellitus, thyroid disease, hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

110 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Diamel

Treatment:

Dietary Supplement: Diamel

B

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo