Women’s Clinical Research

Participating in a clinical trial could give you access to potential new medicines and treatments before they’re available on the market. This can make a significant difference for patients suffering from diseases and conditions that aren’t effectively treated with current treatment options.

Participating in a clinical trial also gives you the opportunity to play a personal role in supporting the development of new drugs that advance health care for everyone.

When you participate in a clinical study, you’re compensated for your time and travel. Additionally, your visits and lab work are free, so your health is monitored and you can learn more about your condition without worrying about expenses.

A clinical study, or clinical trial, is a stepwise process to determine the safety and effectiveness of new medications and treatments. The process begins in the lab, where clinical lab scientists develop and test the medication.

Once the lab tests verify their safety and effectiveness, developers submit reports of their results to the US Food and Drug Administration (FDA). At the same time, they create and send a detailed plan for continuing their research so the FDA can approve the next step: clinical trials with human volunteers.

After the FDA gives the green light to proceed with a clinical trial, the new medicine must successfully pass through three phases before being placed on the market.

At the end of each phase, the FDA reviews the results and may stop the clinical study or allow it to proceed to the next phase:

• Phase 1: The FDA studies safety and dosage during phase 1. This study includes 20 to 100 volunteers and usually runs for several months.
• Phase 2: Experts study the drug’s effectiveness and side effects during phase 2, which may run as long as two years and includes up to 100 participants.
• Phase 3: This phase continues to study effectiveness and monitors adverse reactions. This portion of the study includes 300 to 3,000 volunteers and typically lasts one to four years. Adding more participants and lengthening the study gives researchers better information as to how the drug will affect the targeted population. When the FDA approves the results of phase 3, they also clear the drug for release on the market.
• Phase 4: After the drug hits the market, clinical researchers recruit thousands of volunteers who use the medication to participate in phase 4. These volunteers are continuously monitored to evaluate ongoing safety and effectiveness. Should serious problems arise, the drug is pulled off the market.

New clinical studies are constantly being developed for many different gynecological conditions and treatments. No matter which study you join, you can count on working with a dedicated research team throughout the study.

An example of one study is the endometriosis pain study. During this study, Dr. Fleishman, Dr. Bower, and a team of researchers are evaluating the safety and effectiveness of an investigational drug for treating moderate to severe pain caused in women with endometriosis.