Bremelanotide and desire: what did the RECONNECT trials find?

Who took part and what was compared?

The two RECONNECT trials randomly assigned premenopausal women with acquired, generalised hypoactive sexual desire disorder to bremelanotide or placebo, with neither participants nor the research team knowing the assignment during the 24-week controlled period. Most participants were white and most were enrolled in the United States. This selected group cannot represent every person with a change in desire, and the studies do not establish effects in men or postmenopausal women. The drug developer sponsored the studies and participated in their design, conduct, analysis and reporting.12

What does the desire score mean?

Participants answered questions about sexual desire over the previous four weeks. The resulting score ranges from 1.2 to 6, with a higher score indicating greater desire. In the first trial, the average score rose 0.5 points with bremelanotide versus 0.2 with placebo; in the second it rose 0.6 versus 0.2. These are group averages, not the chance that any individual will benefit. The label analysis included participants who used study treatment and had a follow-up assessment; missing observations and early discontinuation complicate interpretation.12

Did distress and satisfying experiences change too?

The distress question asked how often low desire bothered participants, on a scale from 0 to 4; lower scores mean less bother. In both trials the average score fell 0.7 points with bremelanotide and 0.4 with placebo. The number of satisfying sexual events was a separate outcome, and the difference between groups was not statistically significant. A result on one measure does not guarantee a change on another, and statistical significance alone does not tell a person whether the average difference would matter to them.12

How many people stopped early?

The US label reports that, among participants in its modified analysis population, 40% on bremelanotide versus 13% on placebo stopped the blinded treatment period early in study 1; the corresponding figures were 39% versus 25% in study 2. These figures are not all discontinuations for side effects. They make it important to look beyond average scores and consider missing outcomes, tolerability and whether participants could continue treatment. The label also presents exploratory analyses that take completion into account.1

What were the trade-offs?

In the pooled controlled trials, nausea was reported by about 40% receiving Vyleesi versus 1% receiving placebo. Flushing and headache were also more frequent. The prescription label warns about temporary blood-pressure rises and slower heart rate and lists uncontrolled hypertension and known cardiovascular disease as contraindications. It also describes possible persistent darkening of skin and effects on absorption of some oral medicines. These figures describe the studied product and group, not every product sold as PT-141. For the wider practical context, see the bremelanotide overview.

The US label advises avoiding Vyleesi with oral naltrexone-containing products used for alcohol or opioid addiction, because Vyleesi may substantially reduce naltrexone exposure and treatment failure can have serious consequences. Discuss all medicines with the prescriber; do not stop naltrexone or change treatment on your own.

The US Vyleesi label does not recommend use during pregnancy. Human pregnancy data are insufficient, and animal studies raised concern about possible fetal harm. The label advises effective contraception during treatment and stopping Vyleesi if pregnancy is suspected; contact the prescribing clinician promptly. These statements concern the approved US product, not unverified products sold under the same ingredient name.1

What can a reader take from the studies?

The findings support a specific US prescribing indication, not a universal answer to changes in desire or a measure of relationship quality. Context, physical health, medicines and personal circumstances matter; persistent or distressing changes are worth discussing with a clinician or sexual-health service. Individual experience can differ from the trial average. The Melanotan II comparison explains why these trials cannot be used to prove the effects of a different peptide.12