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The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of Lybrido in increasing the number of satisfactory sexual episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire disorder and low sensitivity for sexual cues (30 subjects per group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | 30 subjects administered a placebo |
|
| sildenafil + testosterone combination drug 1 | Experimental | 30 subjects are given combination drug 1 (sildenafil 25mg and testosterone 0.25mg) |
|
| Sildenafil and testosterone combination drug 2 | Experimental | Sildenafil 50mg and testosterone 0.25mg |
|
| Sildenafil and testosterone combination drug 3 | Experimental | 30 subjects are given sildenafil 25mg and testosterone 0.50mg |
|
| Sildenafil and Testosterone Combination drug 4 | Experimental | 30 subjects are given sildenafil 50mg and testosterone 0.50mg |
|
| Sildenafil 50mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Solid Oral Dosage. Maximum every other day (on an as needed basis) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting. | Efficacy is estimated by self reporting by subjects using daily event questionnaires, recorded within 24 hours after a sexual event. The number of events between a 4-week baseline establishment period will be compared with the number of events during the 8 week double-blind treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual satisfaction | Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks. | 20 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Sexual Medicine | San Diego | California | 92120 | United States | ||
| The Center for Vulvovaginal Disorders |
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30 subjects are given sildenafil 50mg |
|
| Testosterone 0.50mg | Experimental | 30 subjects are given testosterone 0.5mg |
|
| Sildenafil |
| Drug |
Solid Oral Dosage. Maximum every other day (on an as needed basis) |
|
| Testosterone | Drug | Solid Oral Dosage. Maximum every other day (on an as needed basis) |
|
| Sexual desire and arousal | Sexual desire and arousal will be evaluated based on the 'desire' and 'arousal' domains of the Sexual Anamnesis Questionnaire, the Sexual Function questionnaire and weekly diaries throughout the course of the study. | 20 Weeks |
| Sexual motivation and inhibition | Sexual motivation and inhibition will be assessed using the Sexual Motivation Questionnaire and comparing sexual motivation and inhibition between the 4-week establishment period and the 8-week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks. | 20 Weeks |
| Safety and toleration | Safety will be evaluated by: 1) AEs [Number of patients reporting AEs, number of patients reporting drug related AEs] 2)SAE [Number of patients reporting SAEs, number of patients reporting drug related SAEs]and 3) Changes in laboratory safety data [Number of patients reporting abnormal lab safety data, number of patients reporting drug related abnormal lab safety data]. These will be evaluated throughout the course of the study. | 20 Weeks |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| Meridien Research | Brooksville | Florida | 34601 | United States |
| Segal Institute Women's Health Clinic | North Miami | Florida | 33161 | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Meridien Research | St. Petersburg | Florida | 34203 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Annapolis Sexual Wellness Center | Annapolis | Maryland | 21401 | United States |
| Maryland Prime Care Physicians | Stevensville | Maryland | 21666 | United States |
| Center for Sexual Medicine at Sheppard Pratt | Townson | Maryland | 22104 | United States |
| Women's Health Research Center | Plainsboro | New Jersey | 08536 | United States |
| Michael A. Werner, MD PC | Purchase | New York | 10577 | United States |
| Philadelphia Clinical Research | Philadelphia | Pennsylvania | 19114 | United States |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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