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Diamel in the Treatment of Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Phase 3

Locations

Cuba

Study Type

Interventional

Intervention

Diamel

Placebo

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Dietary supplement, Diamel, Polycystic Ovary Syndrome, Female Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

"Ramón González Coro" Gynecologic and Obstetric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Diamel

Placebo

Outcomes

Primary Outcome Measures

Normalization of blood concentrations of androgens at week 24

Normalization of blood concentrations prolactin at week 24

Normalization of blood concentrations of estrogens at week 24

Normalization of blood concentrations of FSH at week 24

Normalization of blood concentrations of LH at week 24

Secondary Outcome Measures

Regularization of the menstrual cycle at week 24.

Reappearance of ovulatory cycles at week 24

Normalization of blood concentrations of insulin at week 24

Normalization of blood concentrations of cholesterol at week 24

Normalization of blood concentrations of triglycerides at week 24

Normalization of blood concentrations of glucose at week 24

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

Full Information

NCT ID

NCT01051024

First Posted

January 15, 2010

Last Updated

May 2, 2012

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT01051024

Brief Title

Diamel in the Treatment of Polycystic Ovary Syndrome

Official Title

Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catalysis SL

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

Dietary supplement, Diamel, Polycystic Ovary Syndrome, Female Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Diamel

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Diamel

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Normalization of blood concentrations of androgens at week 24

Time Frame

24 weeks

Title

Normalization of blood concentrations prolactin at week 24

Time Frame

24 weeks

Title

Normalization of blood concentrations of estrogens at week 24

Time Frame

24 weeks

Title

Normalization of blood concentrations of FSH at week 24

Time Frame

24 weeks

Title

Normalization of blood concentrations of LH at week 24

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Regularization of the menstrual cycle at week 24.

Time Frame

24 weeks

Title

Reappearance of ovulatory cycles at week 24

Time Frame

24 weeks

Title

Normalization of blood concentrations of insulin at week 24

Time Frame

24 weeks

Title

Normalization of blood concentrations of cholesterol at week 24

Time Frame

24 weeks

Title

Normalization of blood concentrations of triglycerides at week 24

Time Frame

24 weeks

Title

Normalization of blood concentrations of glucose at week 24

Time Frame

24 weeks

Title

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

Time Frame

24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mercedes Hernandez, MD

Organizational Affiliation

"Ramón González Coro" Gynecologic and Obstetric Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

"Ramón González Coro" Gynecologic and Obstetric Hospital

City

Havana City

State/Province

Havana

ZIP/Postal Code

10400

Country

Cuba

12. IPD Sharing Statement

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Diamel in the Treatment of Polycystic Ovary Syndrome

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