Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00657501

Acronym

BLOOM

Enrollment

575

Registered

2008-04-14

Start date

2008-03-31

Completion date

2011-09-30

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoactive Sexual Desire Disorder

Keywords

testosterone, hypoactive sexual desire disorder, menopause

Brief summary

This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women.

Interventions

DRUGtestosterone gel

once daily transdermal gel, 300 mcg

DRUGplacebo gel

once daily transdermal placebo gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Must be between the ages of 30 to 65 years * Must have undergone hysterectomy and bilateral salpingo-oophorectomy

Exclusion criteria

* A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation * Any systemic skin diseases or local skin abnormalities in the area of application * Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder). * A medical condition that could affect or interfere with sexual function * Using a systemic transdermal gel or cream estrogen therapy.

Design outcomes

Primary

Measure	Time frame
Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score.	Time Frame: Baseline and 21-24 weeks.

Secondary

Measure	Time frame
Change from baseline over time for multiple efficacy measurements	change over timepoints from baseline period

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026