PCOS Research Study Seeking Women with Polycystic Ovary Syndrome in Florida, Ohio, Virginia and Illinois

Study Title

A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)

Study Description

This research is being done to find out whether a new investigational medication called MLE4901 works to help treat PCOS. MLE4901 is an investigational medication. This means that MLE4901 is still being studied. It also means that the U.S. Food and Drug Administration (FDA) has not approved MLE4901 for the treatment of PCOS. The FDA allows MLE4901 to be used only in research.

This treatment could potentially help to control the symptoms of PCOS such as hirsutism (excessive hair that appears in a male pattern), acne, and alopecia (thinning of hair on the top of the head), as well as improve frequency of menses, ovulation, and quality of life.

Goals

The goal of this study is to evaluate doses of MLE4901 (an investigational treatment) compared to placebo for the treatment of PCOS. It is aimed at evaluating the improvement in the symptoms of PCOS.

Eligibility Criteria

Inclusion Criteria:

  1. At least one of the following during Screening:
    • Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (excessive hair that appears in a male pattern), acne, or androgenic alopecia (hair loss on the top of the head)
    • Biochemical hyperandrogenism refers to an elevated serum androgen level (i.e., elevated total, bioavailable or free testosterone levels)
    • Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian size
  2. Body mass index (BMI) 22 to 45 kg/m2, inclusive
  3. Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
  4. Must be willing to avoid the use of all hair growth procedures and products during study participation

Exclusions

Exclusion Criteria:

  1. Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
  2. Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
  3. Uncontrolled hypo- or hyperthyroidism
  4. Post-hysterectomy or endometrial ablation
  5. Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
  6. Medical history of type 1 or type 2 diabetes mellitus

Compensation

Varies by site. Please use the information below to contact the site near you for details.

Locations — Florida, Ohio, Virginia, Illinois

 

Florida Sites
Tampa, Miami, Jacksonville, Hialeah, Deland, Orlando

Palmetto Professional Research
13055 SW 42nd, Suite 207
Miami, FL 33175

Principal Investigator: Esperanza Arce-Nunez,MD
Site Contact: Yadira Alfonso
Telephone: 208-346-8900
Email: yalfonso@palmettoproresearch.com
Website: https://www.facebook.com/Palmetto-Professional-Research-1234897259915250/

PCOS Study

Stedman Clinical Trials, LLC New Tampa Obgyn
14424 Bruce B Downs Blvd
Tampa, FL 33613
Principal Investigator: Elliot Cazes, MD
Site Contact: Beth Stevens
Telephone: 813-971-8311 ext. 2019
Email: beth_stevens@stedmanclinicaltrials.com
Website: http://www.stedmanclinicaltrials.com/

PCOS Study

Segal Institute for Clinical Research
1065 N.E. 125th Street Suite 221
North Miami, FL 33161
Principal Investigator: Steven Chavoustie, MD
Site Contact: Kimberly Gardner
Telephone: 305-722-1984 ext. 2266
Email: kgardner@segalinstitute.com
Website: http://www.segaltrials.com/enrolling-studies/womens-health-general-medicine-studies/

PCOS Study

University of Florida (UF) – Jacksonville
4549 Emerson Street, Suite 201
Jacksonville, FL 32207
Principal Investigator: Andrew Kaunitz, MD
Site Contact: Melanie Bentley
Telephone: 904-633-0066
Email: melanie.bentley@jax.ufl.edu
Website: http://hscj.ufl.edu/directory/bio/948/andrew-kaunitz/

PCOS Study

Health Care Family Rehab & Research Center
900 West 49th Street, Suite 501
Hialeah, FL 33012
Principal Investigator: Elizabeth Mones, MD
Site Contact: Moya, Maria
Telephone: 305-819-3133
Email: mmoyaresearch@hotmail.com

PCOS Study

Avail Clinical Research, LLC
860 Peachwood Dr.
Deland, FL 32720
Principal Investigator: Melanie VanDemark, MD
Site Contact: Cathy Cohen
Telephone: 386-740-0770 ext. 313
Email: ccohen@availclinical.com
Website: http://www.availclinical.com/trial/polycystic-ovarian-syndrome-pcos/

PCOS Study

Compass Research, LLC
100 West Gore Street, Suite 202
Orlando, FL 32806
Principal Investigator: Judith White
Site Contact: Vanessa Lesnett
Telephone: 407-426-9299
Email: vanessa.lesnett@compass.bioclinica.com
Website: http://www.compassresearch.com/patients/current-studies/womens-health/polycystic-ovary-syndrome-pcos

PCOS Study

 


Ohio Sites
Columbus, Tiffin, Mayfield Heights, Cleveland

Aventiv Research, Inc.
99 N Brice Road, Suite 260
Columbus, OH 43213

Principal Investigator: M. Randy Bressler, MD
Site Contact: Lindsay Newton
Telephone: 614-501-6164
Email: lnewton@aventivresearch.com
Website: http://www.aventivresearch.com/studies/womens-clinical-research-studies.php#polycystic-ovary-syndrome

PCOS Study

Clinical Research of Tiffin
143 S. Monroe
Tiffin, OH 44883
Principal Investigator: Abner Cordero
Site Contact: Jessica Shoemaker
Telephone: 419-934-3116
Email: shoemaker_jlclinicalresearch@yahoo.com

PCOS Study

University Hospitals Case Medical Center
5850 Landerbrook Drive, Suite 300
Mayfield Heights, OH 44124
Principal Investigator: Angelina Gangestad, MD
Site Contact: Margo Riha
Telephone: 216-844-8091
Email: Margo.Riha@UHhospitals.org
Website: http://www.uhhospitals.org/find-a-doctor/gangestad-angelina-11900

PCOS Study

Rapid Medical Research, Inc.
3619 Park East Dr., Suite 109
Cleveland, OH 44122
Principal Investigator: Gita Gidwani, MD
Site Contact: Nicole Genco
Telephone: 216-682-0320 ext. 252
Email: Nicole.genco@rapidmedicalresearch.com
Website: http://rapidmedicalresearch.com/polycystic-ovary-syndrome-pcos-research-study-cleveland-oh/

PCOS Study

 


Virginia Sites
Charlottesville, Norfolk

Charlottesville Medical Research Center, LLC
325 Winding River Lane, Suite 102
Charlottesville, VA 22911

Principal Investigator: James Clark, MD
Site Contact: Kathy Stuples
Telephone: 434-817-2442
Email: kathy@cvillemedresearch.com
Website: http://www.cvillemedresearch.com/current-studies.html

PCOS Study

Tidewater Clinical Research, Inc.
844 Kempsville Road, Suite 208
Norfolk, VA 23502
Principal Investigator: Franklin Morgan, Jr.
Site Contact: April Rusch
Telephone: 757-471-3375 Ext. 111
Email: tcrrusch@cox.net
Website: http://www.tidewaterclinresearch.com/43501.html

PCOS Study

 


Illinois

Womens Health Practice
2125 South Neil Street
Champaign, IL 61820

Principal Investigator: Suzanne Trupin, MD
Site Contact: Treina Smith
Telephone: 217-356-3736
Email: treina.smith@womenshealthpractice.com
Website: http://www.womenshealthpractice.com/clinical-research.php

PCOS Study

Disclaimer

This study is not affiliated with PCOS Challenge, Inc. PCOS Challenge, Inc. does not recommend or endorse any specific studies, tests, physicians, products, procedures, opinions, or other information from third parties that may be mentioned on the PCOS Challenge websites. Any such mention is for information purposes only. Any third party services, products and websites, including those offered by affiliates, sponsors and advertisers, which may be accessed through the PCOS Challenge websites are the sole responsibility of the third party who is offering the service, product or posting the website. PCOS Challenge, Inc. makes no warranty as to the accuracy of any information on third party websites and accepts no liability for any claims, errors, and omissions or for any damage or injury to persons or property arising out of the use or operation of any services, products, materials, instructions, methods, ideas or procedures provided by third parties. Any offers, pricing, and/or promotions offered through the PCOS Challenge websites, affiliates, or any third party are subject change without notice at the sole discretion of the party making the offer. Read Full Disclaimer.

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