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The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome

Phase 3
18 Years
38 Years
Open (Enrolling)
Polycystic Ovary Syndrome

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Trial Information

The Effects of Oral Cinnamon Extract on Menstrual Cyclicity in PolyCystic Ovary Syndrome

Inclusion Criteria:

- Patients aged greater than 18 years of age

- Ability to understand and willingness to comply with the study protocol

- Written informed consent

- Patients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome,
defined by oligomenorrhea or amenorrhea and at least one of the following two signs:
clinical or biochemical evidence of hyperandrogenism or ultrasound finding of
polycystic appearing ovaries.

Exclusion Criteria:

- Current pregnancy or lactation

- Liver disease or elevated liver enzymes

- Established diagnosis of diabetes mellitus

- Abnormal serum glucose levels either at fasting or after the 2-hr oral glucose
tolerance test meeting criteria for the diagnosis of diabetes mellitus according to
the American Diabetes Association.

- Insulin sensitizing treatment within 3 months prior to or during the eight week study

- Hormonal treatment involving estrogen or progesterone 3 months prior to or during the
study period, with the exception of medroxyprogesterone acetate for withdrawal

- Systemic or inhaled corticosteroids.

- Known hypersensitive reaction to cinnamon.

- Patients with seizure disorders, known cardiovascular disease, or cerebrovascular

- Body mass index (BMI)range 20-50 (excluding all women with BMI under 20 or over 50).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of menses during the six month study period.

Outcome Description:

Ovulatory cycles will be confirmed by serum progesterone levels.

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

Rogerio Lobo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Insulin resistance
  • Cinnamon extract
  • Irregular menstrual cycles
  • Ovarian cysts
  • Polycystic Ovary Syndrome



Columbia University Medical Center New York, New York  10032