18+ · Research Use Only · Not for Human Consumption
Bremelanotide · Phase 3 · Completed
RECONNECT (studies 301 and 302)
In RECONNECT (studies 301 and 302), a phase 3 trial of bremelanotide in premenopausal women with hypoactive sexual desire disorder (n=1,267), the FSFI desire domain score difference from placebo was +0.30 points on study 301, 1.75 mg and +0.42 points on study 302, 1.75 mg over 24 weeks (Kingsberg SA et al. Obstet Gynecol 2019 (RECONNECT)).
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Results
| Study 301, 1.75 mg | +0.30 points |
|---|---|
| Study 302, 1.75 mg | +0.42 points |
Distress about low desire (FSDS-DAO item 13) fell 0.37 and 0.29 points more than placebo in studies 301 and 302.
Side effects reported
The most frequently reported adverse events were nausea in 40.0% on 1.75 mg, integrated phase 3 against 1.3% on placebo, flushing in 20.3% on 1.75 mg, integrated phase 3 against 1.3% on placebo, headache in 11.3% on 1.75 mg, integrated phase 3 against 1.9% on placebo and injection site reactions in 5.4% on 1.75 mg, integrated phase 3 against 0.5% on placebo (Safety profile across the clinical programme, J Womens Health 2022 (integrated double-blind phase 3, N=1,247)). The safety review reports nausea as the most common reason for stopping bremelanotide, without a rate.
| Event | 1.75 mg, integrated phase 3 | Placebo |
|---|---|---|
| Nausea | 40.0% | 1.3% |
| Flushing | 20.3% | 1.3% |
| Headache | 11.3% | 1.9% |
| Injection site reactions | 5.4% | 0.5% |
Design
Trial design and sources
- Compound
- Bremelanotide
- Phase
- 3
- Population
- Premenopausal women with hypoactive sexual desire disorder
- Participants randomised
- 1,267
- Duration
- 24 weeks
- Primary endpoint
- Coprimary: change in the FSFI desire domain score and FSDS-DAO item 13 from baseline to end of study
- Estimand
- Not stated in the source read
- Read out
- 1 November 2019
Arm figures are differences from placebo, not changes from baseline. Study 302 is registered as NCT02338960. The safety review reports nausea as the most common reason for stopping bremelanotide, without a rate.
- Kingsberg SA et al. Obstet Gynecol 2019 (RECONNECT) open · checked 23 September 2026
- Safety profile across the clinical programme, J Womens Health 2022 (integrated double-blind phase 3, N=1,247) open · checked 23 September 2026
- ClinicalTrials.gov NCT02333071 open · checked 23 September 2026
- Registry: NCT02333071
Questions
RECONNECT (studies 301 and 302), answered
What did RECONNECT (studies 301 and 302) find?
In RECONNECT (studies 301 and 302), a phase 3 trial of bremelanotide in premenopausal women with hypoactive sexual desire disorder (n=1,267), the FSFI desire domain score difference from placebo was +0.30 points on study 301, 1.75 mg and +0.42 points on study 302, 1.75 mg over 24 weeks (Kingsberg SA et al. Obstet Gynecol 2019 (RECONNECT)).
What side effects were reported in RECONNECT (studies 301 and 302)?
The most frequently reported adverse events were nausea in 40.0% on 1.75 mg, integrated phase 3 against 1.3% on placebo, flushing in 20.3% on 1.75 mg, integrated phase 3 against 1.3% on placebo, headache in 11.3% on 1.75 mg, integrated phase 3 against 1.9% on placebo and injection site reactions in 5.4% on 1.75 mg, integrated phase 3 against 0.5% on placebo (Safety profile across the clinical programme, J Womens Health 2022 (integrated double-blind phase 3, N=1,247)). The safety review reports nausea as the most common reason for stopping bremelanotide, without a rate.