PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Drug to treat hypoactive sexual desire disorder in women of 'very limited use'

Drug approved by the US Food and Drug Administration now shown ineffective - participants preferred a placebo

2021-03-08
(Press-News.org) An independent analysis of the medical trials which formed the final basis of approval by the US Food and Drug Administration (FDA) strongly suggests the drug bremelanotide has very limited effectiveness as a treatment for hypoactive sexual desire disorder (HSDD) in women, and that trial participants preferred a placebo.

The analysis, published today in the peer-reviewed Journal of Sex Research, also highlights issues with the validity of HSDD as a diagnosis. The condition was removed from the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in 2013.

Professor Glen Spielmans, of Metropolitan State University, USA, examined data from bremelanotide's FDA New Drug Application, the clinicaltrials.gov protocol entries for the two 24-week Phase III trials, and the journal article (Kingsberg et al., published in Obstetrics and Gynecology) that reported both trials. He also conducted a meta-analysis of efficacy and dropout data appearing in the FDA application and compared these outcomes to those reported in the journal paper.

Spielmans, a Professor in Psychology, found that 42.1% of trial participants given bremelanotide did not complete the study compared to 20.48% of participants given the placebo, with dropout rates due to adverse events much higher for those on bremelanotide. Among participants who reached the end of the trials' acute phase, 87.22% on the placebo wanted to continue treatment in the open-label phase that followed, compared to 69.97% on bremelanotide.

However, the Kingsberg article did not report that adverse event-induced discontinuation was substantially higher for bremelanotide or that participants preferred taking placebo, measured by the combination of both completing a clinical trial and choosing to participate in the follow-up open-label study.

A number of other problems with the article were found including incomplete data reporting, changed efficacy outcomes and conflicts of interest, with four of the authors working for either the company that conducted the trials (Palatin Technologies) or the company which was licensed to market bremelanotide in North America (AMAG Pharmaceuticals) before the license was transferred back to Palatin.

Professor Spielmans said: "My findings strongly suggest that bremelanotide has very limited treatment efficacy, that the protocol-specified outcomes of bremelanotide are mostly unreported in the main journal article reporting the clinical trial outcomes, and that trial participants would rather take a placebo than bremelanotide."

However, focusing solely on problems with the clinical trials runs the risk of unintentionally reifying the validity of HSDD, he warned. "The lack of specifying symptom duration, questionable validity for the lack of sexual fantasies as a diagnostic criterion, difficulty in disentangling individual sexual problems from relational problems, and the failure to consider cultural influence - including the pressure on women to satisfy the sexual desires of their male partners - in the experience of sexuality all render HSDD as a problematic entity," Professor Spielmans added.

INFORMATION:



ELSE PRESS RELEASES FROM THIS DATE:

Investigating youth suicides among children involved with the welfare system

2021-03-08
Suicide is the second leading cause of death among youth aged 5 to 21 years in the United States. Between 2010 and 2019, suicide rates among this group increased 40%. Youth involved in the child welfare system experience an even greater risk of suicidal behavior, yet research on this vulnerable population is minimal. To better understand and prevent suicide in this at-risk group, researchers at Nationwide Children's Hospital conducted the first study to compare characteristics and health service utilization patterns of youth suicide decedents (those ...

Study suggests wearing a face mask during intense exercise is safe for healthy people

2021-03-08
Wearing a protective face mask has only a modest effect on the ability of healthy people to do vigorous exercise, according to a study published today (Monday) in the European Respiratory Journal [1]. Researchers carried out detailed testing on breathing, heart activity and exercise performance in a group of 12 people while they were using an exercise bike with and without a mask. Although they found differences in some measurements between wearing a mask and not wearing a mask, they say that none of their results indicate any risk to health. This suggests that masks could be worn safely during intense exercise, for example to reduce COVID-19 transmission between ...

One size doesn't fit all when it comes to products for preventing HIV from anal sex

2021-03-06
The initial insights from the study, aptly named DESIRE (Developing and Evaluating Short-acting Innovations for Rectal Use), are being reported on March 6 in a Science Spotlight session at the virtual meeting of the Conference on Retroviruses and Opportunistic Infections (CROI), March 6-10. The presentation will be available for registered participants and media to view throughout the meeting. Conducted by the National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), DESIRE focused on potential delivery methods for rectal microbicides - topical products being developed and tested to reduce ...

"Magic sand" might help us understand the physics of granular matter

2021-03-06
Tokyo, Japan - Researchers from Tokyo Metropolitan University have studied the properties of mixtures of silicone-coated "magic sand", a popular kid's toy, and normal sand. Silicone-coated sand particles were found to interact with each other only, and not with other sand particles. The team discovered that adding silicone-coated sand beyond a certain threshold leads to an abrupt change in clustering and rigidity, a simple, useful way to potentially tune the flow of granular materials for industry. Sand is a fascinating material. It can flow and be poured like a liquid, ...

WRAIR, Duke scientists find evidence of monoclonal antibodies activity against malaria

2021-03-05
Scientists at Walter Reed Army Institute of Research, in a collaboration with Duke University, have confirmed that monoclonal antibodies can be an effective tool in the global fight against malaria. The study, led by Dr. Sheetij Dutta, chief of the Structural Vaccinology Laboratory at WRAIR, showed that mAbs such as CIS43 were most effective in a culture-based assay that measured malaria parasites' ability to infect a human liver cell, while another mAb 317 showed the best activity in a mouse infection model. Dutta added "difference in assay outcomes for mAbs could reflect distinct sites on the circumsporozoite protein that can be exploited for developing improved vaccines." The ...

Physics camp has proven benefits for high school girls

Physics camp has proven benefits for high school girls
2021-03-05
HOUSTON - (March 5, 2021) - Even a small effort up front can boost the abilities and confidence of girls as they anticipate taking challenging science courses. A long-running summer program at Rice University and elsewhere that trains high school girls in basic physics concepts has proven successful in helping them thrive when they take on full courses the next year. When leaders of Rice's two-week day camp looked at similar programs beyond Houston, they found participants scored 3% better in high school physics than their counterparts who did not have the equivalent summer experience. "That doesn't seem like a lot, but it's really hard to move the needle on student outcomes, so 3% is significant," said Carolyn Nichol, an assistant ...

With unfair police treatment, the tragedy is not limited to the incident itself

2021-03-05
BUFFALO, N.Y. - New research using a nationally representative sample of more than 12,000 participants shows the collateral consequences victims are likely to confront following unfair treatment by police. Michael Brown, George Floyd and Tamir Rice are just some of those who have died recently at the hands of police. Their names are now tragically familiar, but thousands of other people who are unjustly stopped, searched or questioned by law enforcement will likely experience a range of detrimental outcomes associated with unfair police treatment, including depression, suicidal thoughts, drug use, and a loss of self-efficacy, according to Christopher ...

Building networks not enough to expand rural broadband

2021-03-05
ITHACA, N.Y. - Public grants to build rural broadband networks may not be sufficient to close the digital divide, new Cornell University research finds. High operations and maintenance costs and low population density in some rural areas result in prohibitively high service fees - even for a subscriber-owned cooperative structured to prioritize member needs over profits, the analysis found. Decades ago, cooperatives were key to the expansion of electric and telephone service to underserved rural areas, spurred by New Deal legislation providing low-interest government grants and loans. Public funding for rural ...

Rapid 3D printing method moves toward 3D-printed organs

2021-03-05
BUFFALO, N.Y. -- It looks like science fiction: A machine dips into a shallow vat of translucent yellow goo and pulls out what becomes a life-sized hand. But the seven-second video, which is sped-up from 19 minutes, is real. The hand, which would take six hours to create using conventional 3D printing methods, demonstrates what University at Buffalo engineers say is progress toward 3D-printed human tissue and organs -- biotechnology that could eventually save countless lives lost due to the shortage of donor organs. "The technology we've developed is 10-50 times faster than the industry standard, and it works with large ...

Online dating: Super effective, or just... superficial?

Online dating: Super effective, or just... superficial?
2021-03-05
According to the Pew Research Center, 1 in 10 American adults have landed a long-term relationship from an online dating app, such as Tinder, OKCupid and Match.com. But what compels people to "swipe right" on certain profiles and reject others? New research from William Chopik, an associate professor in the Michigan State University Department of Psychology, and Dr. David Johnson from the University of Maryland, finds that people's reason for swiping right is based primarily on attractiveness and the race of a potential partner, and that decisions are often made in less than a second. "Despite online dating becoming an increasingly popular way for people to meet one another, ...

LAST 30 PRESS RELEASES:

CABI study reveals major inequalities in global One Health research

Reptiles ‘pee’ crystals, and scientists are investigating what they’re made of

Drug prevents congenital heart block recurrence in a high-risk pregnancy

Wiley announces winners of Advanced Science Young Innovator Award

Towards new ionic liquid-modified zeolite membranes for efficient CO2 conversion

UK Capital's ULEZ quickly cut air pollution —high vehicle compliance may have left little room for further gains after expansion

Retreating glaciers may send fewer nutrients to the ocean

Scientists develop a way to track donor bacteria after fecal microbiota transplants

Telescope hack opens a sharper view into the universe

ASU’s new School of Medicine receives preliminary accreditation, gift and new name

Do fitness apps do more harm than good?

Can blood analyses in dogs provide insights into human aging?

Do some antihistamines increase dementia risk in older hospitalized patients?

How do land use policies contribute to racial segregation in communities?

New method noninvasively measures Achilles tendon structure and function in professional dancers

Does floral scent affect insect visitors and bacterial strains on flowers?

How is radiation therapy portrayed in art?

Emotional strain of fitness and calorie counting apps revealed

Uncovering the biology of growing old

Why do so many pro soccer players develop osteoarthritis?

Successful ground-to-satellite laser communications applying next-generation error correction codes, mitigating atmospheric turbulence

Photosynthesis without the burn

Not hunters but collectors: the bone that challenges the ‘humans wiped out Australian megafauna’ theory

Discovery of new mechanism concerning plasma confinement performance

Humans evolved fastest amongst the apes

Biochar and wetter soils offer breakthrough path to slash farm emissions without cutting crop yields

New biochar-enhanced cement could lock away more carbon dioxide

Strong evidence supports skin-to-skin contact after birth as standard care

Why it’s not just about money: Who goes to the ballet, opera and symphony

Daily step counts of 4,000 or more tied to reduced risk of heart disease, mortality in older women

[Press-News.org] Drug to treat hypoactive sexual desire disorder in women of 'very limited use'
Drug approved by the US Food and Drug Administration now shown ineffective - participants preferred a placebo