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Trial registered on ANZCTR


Registration number
ACTRN12620001356954
Ethics application status
Approved
Date submitted
23/10/2020
Date registered
17/12/2020
Date last updated
17/12/2020
Date data sharing statement initially provided
17/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 302023 0
OVB (Australia) Protocol Number BP101-SD03
Universal Trial Number (UTN)
U1111-1257-2170
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoactive Sexual Desire Disorder 318600 0
Condition category
Condition code
Mental Health 316619 316619 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 318323 0
Treatment: Drugs
Comparator / control treatment
Arm 4: Placebo (benzalkonium chloride and purified water) – two nasal sprays daily (in the morning) for 28 days.
Control group
Placebo

Outcomes
Primary outcome [1] 324744 0
Change in Female Sexual Function Index Desire domain score
Timepoint [1] 324744 0
Baseline and 4 weeks post-commencement of intervention
Primary outcome [2] 324745 0
Change in Female Sexual Distress Scale-Desire/Arousal/Orgasm Item 13 (Bothered by level of sexual desire) score
Timepoint [2] 324745 0
Baseline and 4 weeks post-commencement of intervention
Secondary outcome [1] 385624 0
Change in the standardised number of satisfying sexual events per 28 days (assessed using participant daily diary to be completed with details of each episode of sexual intercourse).
Timepoint [1] 385624 0
Baseline and 4, 8 and 12 weeks post-commencement of intervention
Secondary outcome [2] 385625 0
Change in Female Sexual Function Index Desire domain score
Timepoint [2] 385625 0
Baseline and 8 and 12 weeks post-commencement of intervention
Secondary outcome [3] 385626 0
Change in Female Sexual Distress Scale-Desire/Arousal/Orgasm Item 13 (Bothered by level of sexual desire) score
Timepoint [3] 385626 0
Baseline and 8 and 12 weeks post-commencement of intervention
Secondary outcome [4] 385628 0
Change in the monthly number and proportion of orgasms (standardised to a 28-day period),(assessed using participant daily diary to be completed with details of each episode of sexual intercourse).
Timepoint [4] 385628 0
Baseline and 4, 8 and 12 weeks post-commencement of intervention
Secondary outcome [5] 385629 0
Change in Female Sexual Function Index scores - total scores and individual domain scores (arousal and orgasm) (composite outcome).
Timepoint [5] 385629 0
Baseline and 4, 8 and 12 weeks post-commencement of intervention
Secondary outcome [6] 385630 0
Change in Female Sexual Distress Scale-Desire/Arousal/Orgasm total score
Timepoint [6] 385630 0
Baseline and 4, 8 and 12 weeks post-commencement of intervention
Secondary outcome [7] 385631 0
Patient Global Impression of Severity (PGI-S) scale
Timepoint [7] 385631 0
4, 8 and 12 weeks post-commencement of intervention
Secondary outcome [8] 385633 0
Safety and tolerability (adverse events [e.g. nasal irritation, headache, menstrual cycle changes} determined from participant diary, Investigator assessment; concomitant medications from participant diary, Investigator assessment; vital signs by site assessment; laboratory parameters from analysis of blood and urine samples [haematology, biochemistry, urinalysis, sex hormones/gonadotropins]; 12-lead ECG; Beck Depression Inventory).
Timepoint [8] 385633 0
Adverse events and concomitant medications: Baseline through to 12 weeks post-commencement of intervention
Vital signs: Screening, Baseline (Day 1), 4, 8 & 12 weeks post-commencement of intervention;
Safety Laboratory: Screening, 4, 8 & 12 weeks post-commencement of intervention ;
12-lead ECG: Screening and 4 weeks post-commencement of dosing (end of treatment);
Beck Depression Inventory: Screening, Baseline (day 1), and 4, 8, 12 weeks post-commencement of dosing.
Secondary outcome [9] 389282 0
Patient Global Impression of Improvement (PGI-I) scale
Timepoint [9] 389282 0
4, 8 and 12 weeks post-commencement of intervention

Eligibility
Key inclusion criteria
1) Women aged 21-50 years (inclusive).
2) Pre-menopausal with regular menstrual cycles. Pre-menopausal participants that are currently on menstrual cycle-altering hormonal contraception can be included.
3) Have acquired, generalised hypoactive sexual desire disorder for at least 24 weeks duration prior to Screening.
4) Female Sexual Function Index Desire domain score of less than or equal to 5 at Screening.
5) Female Sexual Distress Scale-Desire/Arousal/Orgasm total score >18 at Screening.
6) 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.
7) Consent to attempt to have sexual activity at least twice per month.
Minimum age
21 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Diagnosed with other sexual dysfunction or mental disorder which may impact sexual function.
2) Beck Depression Inventory score of greater than or equal to 16 during Screening.
3) Have been receiving non-pharmaceutical psychotherapeutic treatment for sexual problems within 12 weeks prior to Screening or planning a psychotherapeutic course during the study.
4) 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 may have a significant impact on sexual activity during the study.
5) 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.
6) History of neurological disorder that would affect cognition.
7) Body mass index (BMI) of greater than or equal to 38.0 kg/m2.
8) History of diagnosed polycystic ovarian syndrome.
9) Cancer in the past, other than basal cell carcinoma or squamous cell carcinoma, that has fully resolved with adequate therapy greater than or equal to five years prior to randomisation.
10) 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.
11) 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.
12) 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.
13) Women who are pregnant, within the first 12 months post-partum, or women who are breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central blocked randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The sample size calculation was based on the co-primary endpoints. To achieve a power of 90% at the significance level of 0.025 by using a t-test (equal variance), a total sample size of 476 participants is planned (15% dropout rate).
The general analytical approach for all endpoints will be descriptive in nature.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,WA,VIC
Recruitment hospital [1] 17613 0
Women’s Health and Research Institute of Australia - Sydney
Recruitment hospital [2] 17614 0
Paratus Clinical Pty Ltd Kanwal Trial Clinic - Kanwal
Recruitment hospital [3] 17615 0
Paratus Clinical Research - Ochre Health Medical Centre Bruce - Bruce
Recruitment hospital [4] 17616 0
Paratus Clinical Pty Ltd Blacktown Trial Clinic - Blacktown
Recruitment hospital [5] 17617 0
Keogh Institute for Medical Research - Nedlands
Recruitment hospital [6] 17618 0
The Royal Women's Hospital - Parkville
Recruitment hospital [7] 18104 0
Austrials - Taringa - Taringa
Recruitment hospital [8] 18105 0
Austrials - Wellers Hill - Tarragindi
Recruitment hospital [9] 18106 0
Paratus Clinical Research - Brisbane - Albion
Recruitment hospital [10] 18107 0
Monash University Public Health and Preventive Medicine - Melbourne
Recruitment postcode(s) [1] 31358 0
2000 - Sydney
Recruitment postcode(s) [2] 31359 0
2259 - Kanwal
Recruitment postcode(s) [3] 31360 0
2617 - Bruce
Recruitment postcode(s) [4] 31361 0
2148 - Blacktown
Recruitment postcode(s) [5] 31362 0
6009 - Nedlands
Recruitment postcode(s) [6] 31363 0
3052 - Parkville
Recruitment postcode(s) [7] 32092 0
4068 - Taringa
Recruitment postcode(s) [8] 32094 0
4121 - Tarragindi
Recruitment postcode(s) [9] 32096 0
4010 - Albion
Recruitment postcode(s) [10] 32098 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 22866 0
New Zealand
State/province [1] 22866 0
Auckland
Country [2] 23227 0
New Zealand
State/province [2] 23227 0
Christchurch

Funding & Sponsors
Funding source category [1] 306446 0
Commercial sector/Industry
Name [1] 306446 0
OVB (Australia) Pty Ltd
Address [1] 306446 0
Suite 2003, Level 20
109 Pitt Street
Sydney NSW 2000
Country [1] 306446 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OVB (Australia) Pty Ltd
Address
Suite 2003, Level 20
109 Pitt Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 306969 0
None
Name [1] 306969 0
Address [1] 306969 0
Country [1] 306969 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306652 0
Bellberry
Ethics committee address [1] 306652 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 306652 0
Australia
Date submitted for ethics approval [1] 306652 0
07/10/2020
Approval date [1] 306652 0
25/11/2020
Ethics approval number [1] 306652 0
Ethics committee name [2] 306713 0
Health and Disability Ethics Committees
Ethics committee address [2] 306713 0
Ministry of Health, Health and Disability Ethics Committees, PO Box 5013, Wellington 6140
Ethics committee country [2] 306713 0
New Zealand
Date submitted for ethics approval [2] 306713 0
07/10/2020
Approval date [2] 306713 0
Ethics approval number [2] 306713 0
Ethics committee name [3] 307394 0
Monash Health Ethics Committee
Ethics committee address [3] 307394 0
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [3] 307394 0
Australia
Date submitted for ethics approval [3] 307394 0
21/10/2020
Approval date [3] 307394 0
16/12/2020
Ethics approval number [3] 307394 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104562 0
Prof Susan Davis
Address 104562 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 104562 0
Australia
Phone 104562 0
+61 03 9903 0684
Fax 104562 0
Email 104562 0
susan.davis@monash.edu
Contact person for public queries
Name 104563 0
Dr Daniil Nemenov
Address 104563 0
OVB (Australia) Pty Ltd
Suite 2003, Level 20
109 Pitt Street
Sydney NSW 2000
Country 104563 0
Australia
Phone 104563 0
+61 02 8999 1199
Fax 104563 0
Email 104563 0
d.nemenov@ovocabio.com
Contact person for scientific queries
Name 104564 0
Prof Susan Davis
Address 104564 0
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Country 104564 0
Australia
Phone 104564 0
+61 03 9903 0684
Fax 104564 0
Email 104564 0
susan.davis@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be grouped per treatment for analysis of safety and efficacy. IPD will not be analysed.
What supporting documents are/will be available?
No other documents available
Summary results
No Results