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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00612742

Acronym

BLOOM

Enrollment

3656

Registered

2008-02-12

Start date

2008-01-31

Completion date

2012-12-31

Last updated

2021-10-29

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

Cardiovascular event, Breast Cancer, Testosterone, Menopause, Hypoactive Sexual Desire Disorder

Brief summary

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Interventions

DRUGtestosterone gel

once daily transdermal testosterone 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

50 Years to No maximum

Healthy volunteers

Inclusion criteria

Postmenopausal female subjects * at least 50 years of age * with at least two points of cardiovascular risk * with a clinical diagnosis of HSDD.

Exclusion criteria

Subjects must not * require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators, * have used androgen therapy within 2 months of randomization, * have a history of estrogen-dependent neoplasia or any gynecologic cancer, * have a history of cancer of any kind in the past 10 years prior to randomization, * have a history of malignant melanoma or a history of invasive cancer at any time, * have a screening mammogram with any finding that requires follow up within 6 months of randomization, * have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization, * have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.

Design outcomes

Primary

Measure	Time frame
The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.	2011 primary outcome analysis for NDA submission

Countries

Canada, United States

Outcome results

None listed

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