Skip to main content
OpenTrials
Completed

NCT Number: NCT01051024

Diamel in the Treatment of Polycystic Ovary Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Infertility, Female Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diamel

Dietary Supplement

Two Diamel tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.

Placebo

Dietary Supplement

Two Placebo tablets (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 24 weeks.

Primary outcomes

  1. Normalization of blood concentrations of androgens at week 24

    Time frame: 24 weeks

  2. Normalization of blood concentrations prolactin at week 24

    Time frame: 24 weeks

  3. Normalization of blood concentrations of estrogens at week 24

    Time frame: 24 weeks

  4. Normalization of blood concentrations of FSH at week 24

    Time frame: 24 weeks

  5. Normalization of blood concentrations of LH at week 24

    Time frame: 24 weeks

Secondary outcomes

  1. Regularization of the menstrual cycle at week 24.

    Time frame: 24 weeks

  2. Reappearance of ovulatory cycles at week 24

    Time frame: 24 weeks

  3. Normalization of blood concentrations of insulin at week 24

    Time frame: 24 weeks

  4. Normalization of blood concentrations of cholesterol at week 24

    Time frame: 24 weeks

  5. Normalization of blood concentrations of triglycerides at week 24

    Time frame: 24 weeks

  6. Normalization of blood concentrations of glucose at week 24

    Time frame: 24 weeks

  7. Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 18, 2010
Registry last updated
May 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.