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Natural Hormone Replacement Therapy Study

Natural Hormone Replacement Therapy Study
Erika Schwartz, M.D.

March, 2003

Dear Women of Power Surge,

Firstly, I would like to express my appreciation to Alice Stamm (Dearest) for permitting me to reach so many of you via Power Surge.

I am running a new nationwide study to see if natural estrogen and progesterone cream by prescription, compared to over-the-counter preparations (progesterone cream, black cohosh, evening oil of primrose), does really relieve the vasomotor symptoms of:

  • hot flashes
  • nightsweats
  • and insomnia
This study will be partly funded by Health Magazine and will be conducted by myself and The International Hormone Institute, a non-profit corporation dedicated to women's health.

If you are between the ages of *approximately 45 and 60 (* exceptions will be made on an individual basis), have all of the above three symptoms and are in otherwise good health, you may be eligible to participate in the three month study. If you, or someone you know, might be interested in this study, you will first need to fill out our Patient Evaluation Form (see information below).

Only through scientific research such as this can we hope to provide women with safe, effective options to traditional hormone replacement therapy to relieve their symptoms.

Let me tell your more about the study:

Natural Alternatives to Hormone Replacement Therapy


Our hypothesis is that Natural Hormone Therapy (FDA approved estradiol / micronized progesterone) by prescription is more effective and consistent at relieving certain symptoms of hormone imbalance than alternative medical treatments (over-the- counter progesterone cream preparations and herbals) and placebo.

The aim of this study is to find out (prove) if certain alternative treatments work for the relief of symptoms of hormone imbalance (hot flashes, nightsweats, insomnia) and to provide evidence that natural hormone therapy by prescription is a safe and more effective option that the over-the-counter preparations and placebo.

The method to assess the effectiveness of natural hormones by prescription vs over-the- counter progesterone cream vs placebo cream vs herbal (black cohosh/oil of evening primrose) pills vs placebo pills will be in a small 5 arm, placebo controlled 3 month pilot study comparing the creams, the herbals and placebos to each other. 100 healthy women between the ages of 45-60 who have all three symptoms will be qualified for the study and randomly placed into one of the 5 treatment groups (20 in each group). The treatments will be packaged uniformly, marked A,B,C,D,E with no distinguishing marks and in no order, by the laboratory.

The investigators will send to the qualified participants a treatment for 3 months by registered mail. The participants will keep a daily log and will be contacted on a monthly basis for follow-up and data collection. At the end of the study, the data will be analyzed (as per the biostatistics unit consultation) by the investigators and the data and interpretation will initially be made available to Health Magazine.

The significance of this study is to, hopefully, provide a safe, effective, user-friendly treatment option for millions of women to use for certain symptoms of hormone imbalance (hot flashes, night sweats, insomnia) to improve their quality of life.

We need your help. Please click here for "The Patient Evaluation" Form.

Download a free copy of Adobe Acrobat Reader

The Patient Evaluation Form requires Adobe Acrobat Reader.  If you don't have Adobe Acrobat, you can download it here for FREE

Print out the form (by clicking on "File" and "Print") and fill it out.

Fax the completed form to 914.747.9080, or mail to my office:

Natural Hormone Therapy Study
200 Saw Mill River Road
Hawthorne, NY 10532

If you qualify for the study, you will be sent full details and an informed consent. Participation is totally voluntary.

If you have any questions about the study, feel free to phone 1.866.DrErika.

Thank you for your help.

Erika Schwartz, M.D.
Maria E. Levada M.D.





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