NCT01051024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

1.4 years

First QC Date

January 15, 2010

Last Update Submit

May 2, 2012

Conditions

Polycystic Ovary Syndrome

Keywords

Dietary supplementDiamelPolycystic Ovary SyndromeFemale Infertility

Outcome Measures

Primary Outcomes (5)

  • Normalization of blood concentrations of androgens at week 24

    24 weeks

  • Normalization of blood concentrations prolactin at week 24

    24 weeks

  • Normalization of blood concentrations of estrogens at week 24

    24 weeks

  • Normalization of blood concentrations of FSH at week 24

    24 weeks

  • Normalization of blood concentrations of LH at week 24

    24 weeks

Secondary Outcomes (7)

  • Regularization of the menstrual cycle at week 24.

    24 weeks

  • Reappearance of ovulatory cycles at week 24

    24 weeks

  • Normalization of blood concentrations of insulin at week 24

    24 weeks

  • Normalization of blood concentrations of cholesterol at week 24

    24 weeks

  • Normalization of blood concentrations of triglycerides at week 24

    24 weeks

  • +2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Diamel

Dietary Supplement: Diamel

B

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

DiamelDIETARY_SUPPLEMENT

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

A
PlaceboDIETARY_SUPPLEMENT

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

B

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Two of the following criteria:
  • Oligo or Anovulation
  • Polycystic Ovary diagnosed by ultrasound technique
  • Clinical signs of Hyperandrogenism
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility, Female

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesInfertility

Study Officials

  • Mercedes Hernandez, MD

    "Ramón González Coro" Gynecologic and Obstetric Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 4, 2012

Record last verified: 2012-05

Locations

CU(1)