---
title: "RECONNECT (studies 301 and 302): Bremelanotide Phase 3"
url: https://www.primaralabs.com/research/trials/reconnect
source: Primara Labs, markdown mirror of the HTML page
---

# 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)).

Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.

Updated 24 September 2026

## Results

*FSFI desire domain score difference from placebo*

| 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](https://doi.org/10.1097/AOG.0000000000003500) · checked 23 September 2026
-   Safety profile across the clinical programme, J Womens Health 2022 (integrated double-blind phase 3, N=1,247) [open](https://doi.org/10.1089/jwh.2021.0191) · checked 23 September 2026
-   ClinicalTrials.gov NCT02333071 [open](https://clinicaltrials.gov/study/NCT02333071) · 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.

Related

## More on bremelanotide

-   [Evidence Map: Bremelanotide](https://www.primaralabs.com/research/evidence#bremelanotide)
-   [PT-141 10mg](https://www.primaralabs.com/marketplace/pt-141-10mg)