Conditions: Female Orgasmic Disorder
Keywords: Testosterone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 253
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2 intranasal testosterone gel to placebo on the occurrence of orgasm.

Detailed description:

Arms:
arm 1: Placebo intranasal gel administered prn, 2-8 hours before a planned sexual event arm 2: Low dose TBS-2 (0.6 mg) testosterone intranasal gel administered prn arm 3: Medium dose TBS-2 (1.2 mg) testosterone intranasal gel administered prn arm 4: High dose TBS-2 (1.8 mg) testosterone intranasal gel administered prn

Interventions: intervention 1: Placebo intervention 2: Low dose TBS-2 intervention 3: Medium dose TBS-2 intervention 4: High dose TBS-2
Intervention descriptions: intervention 1: placebo intranasal gel administered prn, 2-8 hours before a planned sexual event intervention 2: Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event intervention 3: Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event intervention 4: High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Protocol document: