Pill-plus oral contraceptive pill boosts sexual desire in women: BioSante

 
Pill-Plus, an oral contraceptive pill currently in development, has been shown to boost sexual desire and activity in women.

Pill-Plus is a combination of three sex hormones to be used as a means to prevent pregnancy in women.

Many women who use oral contraceptive pills have reduced sexual desire, arousabilty and sexual activity due to the effects of estrogen and progestogen in normal oral contraceptive pills.

Pill-Plus is found to be restoring testosterone levels that are significantly suppressed during oral contraceptive use in a clinical study.
A condition known as female sexual dysfunction (FSD) in oral contraceptive users, among other potential benefits, could be improved by adding an androgen, e.g., DHEA or testosterone to the oral contraceptive regimen.

A clinical study using  “triple hormone” oral contraceptive Pill-Plus results showed an increase in the frequency of sexual activity and reduced frequency of rejection of initiation of sexual activity by partner.

The study conducted in 82 women comprising a cross-over design of two treatment periods of five months each compared use of an oral contraceptive alone to the same oral contraceptive with the addition of an oral androgen (DHEA).

The study was performed by Dr. Rik van Lunsen and Dr. Ellen Laan from the Department of Sexology of the Academic Medical Center in Amsterdam, The Netherlands in close collaboration with the Professor Herjan Coelingh Bennink and Dr. Yvette Zimmerman from Pantarhei Bioscience in The Netherlands.

First results were reported on May 20, 2010 at the 11th Congress of the European Society of Contraception in The Hague, The Netherlands. .

In addition to this completed study, Pantarhei is engaged in several other Phase II/III clinical studies of the Pill-Plus.

The objectives of the other studies are many, including investigating the effect of restoration of testosterone levels by oral DHEA on the pharmacokinetics of oral contraceptives and the effects of adding DHEA to oral contraceptive treatment on sexual function and other measures including mood, muscle mass and fat and bone parameters.
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“We look forward to additional clinical results in the Pill-Plus’ development program in the next 12 months. These efforts by Pantarhei in women taking oral contrceptives, in addition to our Phase III LibiGel clinical program in the treatment of FSD in menopausal women, highlight BioSante as a leader in women’s sexual health in the United States,”
stated Stephen M. Simes, BioSante’s president & CEO.

The Pill-Plus United States patents for oral use are licensed by BioSante to Pantarhei Bioscience, a Netherlands-based pharmaceutical company, for development and marketing in the United States. BioSante retains rights to the Pill-Plus for transdermal development and marketing.

Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands.

Pantarhei develops in the clinic, patent protected new medical uses of existing molecules (hormones, biologicals and approved drugs) in Women’s Health and Endocrine Cancer.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology.

BioSante’s lead products include LibiGel (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, and Elestrin (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante’s licensee.

BioSante also is developing a portfolio of cancer vaccines (GVAX), three of which have been granted orphan drug designation, and are currently in several Phase II clinical trials.

Other products in development are Bio-T-Gel, a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology.