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Center for Women's Health Research at UNC

The Center for Women’s Health Research at UNC (CWHR) has recently added two new clinical trials to the list of 15 women’s health focused projects they administer.

Dr. Gretchen Stuart, Division of Women’s Primary Health, is the lead-investigator on both trials centered on contraceptives.

The first trial, A Phase 3, Randomized, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System (20 mcg/day) and Mirena® for Long-Term, Reversible Contraception up to Five Years, is an industry initiated and sponsored clinical trial from Medicines 360 to assess the efficacy of a levonorgestrel releasing intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who request long-term, reversible contraception.

The second trial, Pharmacokinetics, Pharmacodynamics, and Genital Tract Viral Shedding in HIV+ Women Using Combined Oral Contraceptives and Raltegravir, is an an investigator-initiated clinical trial from Mereck that will measure pharmacokinetics (PK) and pharmacodynamics (PD) of raltegravir and contraceptive steroids across menstrual cycles in women concomitantly using combined oral contraceptives (COCs) and raltegravir. It will also measure virologic and immunologic changes in the female genital tract before and after initiating combined oral contraceptives.

The two trials span five and two years respectively with a combined award amount of $836,216.

Stuart also recently submitted an application, with the assistance of CWHR, which would allow the University of North Carolina at Chapel Hill to join the NIH/NIHCD Contraceptive Clinical Trials Network (CCTN) as a female site to evaluate new female contraceptives.

The Center continues to support investigators seeking new opportunities in research and collaboration, including gynecological cancer research.  Since February 2012, 12 proposals with a total potential subcontract award amount of over $18 million have been submitted through CWHR. Two other proposals have recently received favorable scores with an anticipation award value of almost $4 million. The Center exceeds the average funding success-rate by 15 percent.

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