Health TrialsbyHealthPanel

Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder

ConditionsFemale Sexual Arousal DisorderFemale Sexual Dysfunction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age21-60
SponsorBiozeus Biopharmaceutical S.A.

About this trial

To determine the efficacy in increasing sexual arousal, safety and tolerability of BZ371A in gel form applied to women with sexual arousal disorder.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women between the ages 21 and 60;

Pre-menopausal or post-menopausal women may be included;

May or may not be taking female sex hormones (estrogen with or without progesterone, or their derivatives);

FSAD, defined as the inability, persistent or recurrent, to obtain or maintain until the conclusion of sexual activity an adequate genital response to sexual arousal (lubrication, warmth and enlargement of the clitoris);

Disqualifiers

Women who do not agree to use a contraceptive method and who have the capacity to become pregnant during the study;

Women who do not agree to attempt sexual activity at least twice a week while taking the study medication;

History of unresolved sexual trauma or abuse;

Diagnosis of vaginismus, genitopelvic pain/penetration disorder and/or sexual aversion disorder;

Trial design

Design model

Crossover

Treatments tested in this trial

  • BZ371A 7.5 mg (1.5 ml)

    Drug

    7.5 mg gel

  • BZ371A 5.0 mg (1.0 ml)

    Drug

    5.0 mg gel

  • BZ371A 2.5 mg (0.5 ml)

    Drug

    2.5 mg gel

  • Placebo (1.5 ml)

    Drug

    BZ371A-matched placebo

  • Placebo (1.0 ml)

    Drug

    BZ371A-matched placebo

  • Placebo (0.5 ml)

    Drug

    BZ371A-matched placebo

Treatment groups

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group A - BZ371A, then PlaceboExperimental treatment 2 interventions
Group B: Group B - Placebo, then BZ371AExperimental treatment 2 interventions
Group C: Group C - BZ371A, then PlaceboExperimental treatment 2 interventions
Group D: Gorup D - Placebo, then BZ371AExperimental treatment 2 interventions
Group E: Group E - BZ371A, then PlaceboExperimental treatment 2 interventions
Group F: Group F - Placebo, then BZ371AExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Efficacy in increasing arousal

Evaluation of the efficacy of BZ371A in increasing arousal using Female Sexual Encounter Profile (FSEP) questionnaire. The study will evaluate number of "yes" answers to question 3 in the Female Sexual Encounter Profile (FSEP) questionnaire, divided by the number of valid attempts (question 7 of the FSEP). The study will evaluate the increase in the FSEP score based on the baseline FSEP value, obtained before using the BZ371A. Thus, the higher the number of yes answers, the better the efficacy of the drug.

Time frame
Baseline, 4 weeks and 8 weeks

Secondary outcomes

1

Efficacy in increasing desire, lubrification, orgasm and arousal

Evaluation of the success rate for desire, lubrification, orgasm and for arousal using Female Sexual Encounter Profile (FSEP). The number of successes for desire will be assessed using FSEP Question 2 / FSEP Question 7, for lubrication FSEP Question 4 / FSEP Question 7, for orgasm FSEP Question 5 / FSEP Question 7 and for the degree of arousal FSEP Question 6 / FSEP Question 7. For each question, the number of "yes" answers will be counted as success. Therefore, for each "no" answer the value will be 0 and for each "yes" answer the value will be 1.

Time frame
Baseline, 4 weeks and 8 weeks
2

Evaluation of the quality of female sexual encounters

Evaluation based on the total score of the Female Sexual Encounter Profile (FSEP) questionnaire. The score ranges from 0 to 9. Therefore, the higher the score, the better the participant's sexual encounter.

Time frame
Baseline, 4 weeks and 8 weeks
3

Efficacy in increasing genital blood flow

Evaluation of the efficacy of BZ371A in increasing genital blood flow using Cytocam system

Time frame
Baseline, 4 weeks (pre-dose, 15, 30, 60, 90 and 120 minutes) and 8 weeks (pre-dose, 15, 30, 60, 90 and120 minutes)
4

Female Sexual Function Index (FSFI)

Evaluation of the score for each domain (Desire, Arousal, Lubrication, Orgasm, Satisfaction, Pain) using the Female Sexual Function Index (FSFI) questionnaire. The score ranges from 2 to 36. Thus, the higher the score, the better the participant's sexual satisfaction.

Time frame
Baseline, 4 weeks and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biozeus Biopharmaceutical S.A.

Lead sponsor

Source ClinicalTrials.gov
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