A Phase II, multicentre, double-blind, randomised, placebo-controlled trial to demonstrate the efficacy and safety of BP101 in patients with hypoactive sexual desire disorder.
OVB (Australia) Pty Ltd
476 participants
Jan 27, 2021
Interventional
Conditions
Summary
This is a multicentre, double-blind, phase II study to evaluate the efficacy, safety and tolerability of BP101, administered as two nasal sprays once daily for 28 days, in pre-menopausal women with HSDD. Participants will be randomly assigned to receive one of three different doses of BP101, or placebo. Study assessments include safety checks including vital signs, physical exam and blood tests, and questionnaires to determine whether BP101 can improve sexual function and desire.
Eligibility
Inclusion Criteria7
- Women aged 21-50 years (inclusive).
- Pre-menopausal with regular menstrual cycles. Pre-menopausal participants that are currently on menstrual cycle-altering hormonal contraception can be included.
- Have acquired, generalised hypoactive sexual desire disorder for at least 24 weeks duration prior to Screening.
- Female Sexual Function Index Desire domain score of less than or equal to 5 at Screening.
- Female Sexual Distress Scale-Desire/Arousal/Orgasm total score >18 at Screening.
- In a stable relationship with the same sexually active partner for greater than or equal to 1 year. The partner must be physically available for greater than or equal to 50% of time throughout the study and must not have any sexual dysfunctions.
- Consent to attempt to have sexual activity at least twice per month.
Exclusion Criteria13
- Diagnosed with other sexual dysfunction or mental disorder which may impact sexual function.
- Beck Depression Inventory score of greater than or equal to 21 during Screening.
- Have been receiving non-pharmaceutical psychotherapeutic treatment for sexual problems within 12 weeks prior to Screening or planning a psychotherapeutic course during the study.
- If in the Investigator’s opinion the participant has obvious life stress conditions (death of someone close, legal or financial difficulties), personal problems in relationships, or relationship problems with their partner that are not sexual discord arising from the problems of HSDD, that may have a significant impact on sexual activity during the study.
- History of chronic diseases of the nasal cavity and nasopharynx or rhinitis and/or other acute inflammatory diseases of the nasal cavity or nasopharynx within four weeks prior to randomisation.
- History of neurological disorder that would affect cognition.
- Body mass index (BMI) of greater than or equal to 38.0 kg/m2.
- History of diagnosed polycystic ovarian syndrome.
- Cancer in the past, other than basal cell carcinoma or squamous cell carcinoma, that has not fully resolved with adequate therapy greater than or equal to five years prior to randomisation.
- History of inflammatory diseases of pelvic organs, infections of the genitourinary system, cervicitis, interstitial cystitis, vulvodynia or severe atrophy of the vaginal epithelium, or any other chronic gynaecological pathology within four weeks prior to Screening, or at any time in the past if, in the Investigator’s opinion, it may interfere with normal sexual activity.
- History of surgical interventions (other than cosmetic surgeries) on reproductive organs which result in dyspareunia, impede sexual activity, require maintenance sex hormone therapy, and/or lead to a decrease in sensitivity during sexual events.
- Current clinically significant or unstable comorbidity or pathology which, in the Investigator’s opinion, may interfere with normal sexual activity, precludes the inclusion of the participant for safety purposes, or may affect the outcomes of the study.
- Women who are pregnant, within the first 12 months post-partum, or women who are breastfeeding.
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Interventions
Arm 1: BP101 – two nasal sprays (0.9 mg) daily (in the morning) for 28 days. Arm 2: BP101 – two nasal sprays (1.8 mg) daily (in the morning) for 28 days. Arm 3: BP101 – two nasal sprays (2.52 mg) daily (in the morning) for 28 days. Participant daily diary (accessed via web login or app on handheld device) to be completed with date/time of drug administration. Study drug compliance will be considered acceptable if the participant has taken the drug for greater than or equal to 80% of the scheduled course (e.g. 22 of 28 planned treatment days).
Locations(12)
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ACTRN12620001356954