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How the Latest “Pink Pill” Studies Tested Women’s Sex Drive--and Failed

By EmpowHER
 
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It’s all but official. Hopes have been dashed, once again, for a “pink pill” that can boost low sex drive in females as quickly as the popular “blue pill” Viagra pumps up sex organs in males.

The German pharmaceutical company Boehringer Ingelheim recently released results from two large studies of pre-menopausal women who were treated for diminished sex drive with the drug flibanserin.

In a word, flibanserin flopped--at least in improving libido in most women tested. More studies are underway, but these recent results reconfirm that female sexuality is complicated and may not easily lend itself to a single pharmaceutical product.

Specifics on how the clinical trials were organized and what the results showed were made public this week in a large summary document from the Food and Drug Administration (FDA). See highlights of the study details and results below.

This information, plus the testimony from many experts in women’s health and female sexual dysfunction, will help a panel of analysts decide if flibanserin should be recommended for marketing to the public.

Details of the studies:
More than 1,200 pre-menopausal U.S. and Canadian women in long-term monogamous relationships received flibanserin in two double blind clinical experiments. A double blind study means neither the volunteer in the study nor the administrator knows which pill a volunteer receives—the real drug or a placebo pill-- until the end of the study. This keeps the volunteers and researchers from being swayed by their expectations for a positive or negative outcome while the study is underway. Four doses of flibanserin were tested in the treatment groups of women: 25 milligrams, twice per day; 50 milligrams, once per day; 50 milligrams, twice per day; and 100 milligrams, once per day.

The major goals of the two clinical trials were to examine safety and efficacy of flibanserin, standard objectives for what are called “phase III” clinical trials. Researchers looked at how well flibanserin improved the sexual activity and desire in the volunteers and also determined if any side effects occurred and how often.

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