Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Trial abstract · §3

RECONNECT-301 — results

Primary endpoint, absolute and relative effect where derivable, and harms as reported.

Document identifier
CEI-TR-0133/3
Series
Trial abstract
Version
2.2
Published
21 Mar 2023
Last reviewed
21 Oct 2023
Next review
21 Oct 2025
Identifier
10.71829/cei.trial.133
Certainty
Moderate
Cycle
2023 Q1
Phase
Phase 3
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Change in the Female Sexual Function Index desire domain score and in the associated distress measureA statistically significant but numerically small improvement in desire and distress scoresModerate
Reproduced from the published report. Where the report states a confidence interval the Institute reproduces it; where it does not, none is constructed.

§3.2Endpoint hierarchy

§3.3Harms as reported

Table 5. Adverse events for PT-141 (bremelanotide) from the safety tables the Institute holds for this compound. Where a row names a different trial as its source, the figure is from that trial and not from this one.

EventActive, %Comparator, %Source trial
Nausea40.01.3RECONNECT pooled
Flushing20.30.3RECONNECT pooled
Injection-site reaction13.28.0RECONNECT pooled
Headache11.31.9RECONNECT pooled
Vomiting4.80.3RECONNECT pooled
Focal hyperpigmentation1.20.0RECONNECT pooled; more frequent with repeated dosing and on the face, gingiva and breasts
Transient blood-pressure increaseA mean rise of approximately 6 mmHg systolic peaking at 2–4 hours, with compensatory heart-rate reduction
Discontinuation for adverse events18.02.0RECONNECT pooled
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