Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000266864
Ethics application status
Approved
Date submitted
21/12/2020
Date registered
11/03/2021
Date last updated
3/04/2024
Date data sharing statement initially provided
11/03/2021
Date results information initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Women’s and Health Practitioner's Perspectives, Experiences and Preferences of Intrauterine Contraceptive Devices
Scientific title
Women’s and Health Practitioner's Perspectives, Experiences and Preferences of Intrauterine Contraceptive Devices
Secondary ID [1] 303061 0
Sponsor Alyra Biotech Pty Ltd protocol number - ALYRA11225181
Universal Trial Number (UTN)
U1111-1262-7813
Trial acronym
WVID
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Dysmenorrhea 320123 0
Pelvic Pain 320124 0
Condition category
Condition code
Reproductive Health and Childbirth 318070 318070 0 0
Contraception

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The protocol is an opt-in survey to be completed online via SurveyMonkey. The questions have been developed specifically for both end-user groups by the investigators. The Group 1 survey contains a validated survey (WaLIDD score, Teheran et al. 2018; these questions can be viewed in the updated survey Q11-14). Alyra Biotech wishes to develop an optimal intrauterine contraceptive device, otherwise known as IUCDs, for young women with period or pelvic pain. We wish to determine the priorities of two end-user groups: Group 1) women who choose or are considering choosing an IUCD for contraception, and Group 2) health professionals who offer IUCD insertion to patients. The surveys are anticipated to take participants an average of 20 minutes (Group 1) and 10 minutes (Group 2). We wish to research the experiences, perspectives and preferences of both end-user groups to assist us in planning an optimal device for women with pain. The views and experiences of our end user groups will guide our product development. Finally, to ensure that our product is commercially feasible, we wish to determine the cost premium that users, or prescribers, of the device would accept for such a device. As we are targeting two end-user groups, the surveys will be suited to either patients or a health professional who offer IUCD insertion to patients.
Intervention code [1] 319346 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326057 0
To understand women's perspectives of IUCDs assessed using an investigator led survey that includes the WaLIDD score to assess dysmenorrhea symptoms in Group 1 participants.
Timepoint [1] 326057 0
Group 1 survey assessed at one-time.
Primary outcome [2] 326357 0
To understand Health Practitioner's concerns regarding IUCD use and insertion using investigator led questions.
Timepoint [2] 326357 0
Group 2 survey assessed at one-time.
Secondary outcome [1] 389991 0
To determine whether women concerned about the potential for pain in the 3 months following device insertion would be prepared to pay a premium price for such a device using specific investigator led questions.
Timepoint [1] 389991 0
Group 1 survey assessed at one-time.
Secondary outcome [2] 391166 0
To determine whether Health Practitioner's who insert IUCDs would prefer to offer a new device that reduced pain by 50% for 3 months post-insertion to their patients with gynaecological symptoms over currently available IUCDs using specific investigator led questions.
Timepoint [2] 391166 0
Group 2 survey assessed at one-time.
Secondary outcome [3] 391167 0
To determine whether Health Practitioner's perspectives on how much extra money their patients with gynaecological symptoms would pay to choose a new IUCD that reduced pain by 50% for 3 months post-insertion using specific investigator led questions.
Timepoint [3] 391167 0
Group 2 survey assessed at one-time.
Secondary outcome [4] 391168 0
To determine whether women who experience period or pelvic pain would be prepared to try a new IUCD that reduced their pain by 50% in the 3 months following device insertion using specific investigator led questions.
Timepoint [4] 391168 0
Group 1 survey assessed at one-time.

Eligibility
Key inclusion criteria
Group 1
• Over 18 years of age
- Have or have had regular periods
• Are able to comprehend the written information provided

Group 2
- Are a registered Health Practitioner who offers IUCDs as form of contraception
- Are able to comprehend the written information provided
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to read or comprehend English for both Groups.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Statistical planning has been undertaken in consultation with Professor Adrian Esterman, of Public Health Perspectives Pty Ltd. Research responses will be downloaded from SurveyMonkey into SPSS software for analysis. Initial statistical analysis will be completed using the statistical analysis available through SurveyMonkey. Further statistical analysis will be undertaken by Professor Adrian Esterman, and transferred to Professor Esterman via a secure file transfer. Data will be stored on his secured analysis system.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2021
Actual
11/03/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
28/02/2024
Date of last data collection
Anticipated
31/12/2023
Actual
28/02/2024
Sample size
Target
400
Accrual to date
Final
399
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 23305 0
New Zealand
State/province [1] 23305 0
Country [2] 23306 0
Belgium
State/province [2] 23306 0
Country [3] 23307 0
Austria
State/province [3] 23307 0
Country [4] 23308 0
Argentina
State/province [4] 23308 0
Country [5] 23309 0
Brazil
State/province [5] 23309 0
Country [6] 23310 0
Bolivia
State/province [6] 23310 0
Country [7] 23311 0
Bulgaria
State/province [7] 23311 0
Country [8] 23312 0
Canada
State/province [8] 23312 0
Country [9] 23313 0
China
State/province [9] 23313 0
Country [10] 23314 0
Bangladesh
State/province [10] 23314 0
Country [11] 23315 0
Czech Republic
State/province [11] 23315 0
Country [12] 23316 0
Denmark
State/province [12] 23316 0
Country [13] 23317 0
Finland
State/province [13] 23317 0
Country [14] 23318 0
France
State/province [14] 23318 0
Country [15] 23319 0
Germany
State/province [15] 23319 0
Country [16] 23320 0
Greece
State/province [16] 23320 0
Country [17] 23321 0
Hong Kong
State/province [17] 23321 0
Country [18] 23322 0
Hungary
State/province [18] 23322 0
Country [19] 23325 0
India
State/province [19] 23325 0
Country [20] 23326 0
Indonesia
State/province [20] 23326 0
Country [21] 23327 0
Ireland
State/province [21] 23327 0
Country [22] 23328 0
Iceland
State/province [22] 23328 0
Country [23] 23329 0
Italy
State/province [23] 23329 0
Country [24] 23330 0
Japan
State/province [24] 23330 0
Country [25] 23331 0
Korea, Republic Of
State/province [25] 23331 0
Country [26] 23332 0
Netherlands
State/province [26] 23332 0
Country [27] 23333 0
Nigeria
State/province [27] 23333 0
Country [28] 23334 0
Norway
State/province [28] 23334 0
Country [29] 23335 0
Poland
State/province [29] 23335 0
Country [30] 23336 0
Romania
State/province [30] 23336 0
Country [31] 23337 0
Russian Federation
State/province [31] 23337 0
Country [32] 23338 0
South Africa
State/province [32] 23338 0
Country [33] 23339 0
Sweden
State/province [33] 23339 0
Country [34] 23340 0
Switzerland
State/province [34] 23340 0
Country [35] 23341 0
Ukraine
State/province [35] 23341 0
Country [36] 23342 0
United Kingdom
State/province [36] 23342 0
Country [37] 23343 0
United States of America
State/province [37] 23343 0

Funding & Sponsors
Funding source category [1] 307468 0
Commercial sector/Industry
Name [1] 307468 0
Alyra Biotech Pty Ltd
Country [1] 307468 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alyra Biotech Pty Ltd
Address
PO Box 4025 Norwood South, SA, 5067
Country
Australia
Secondary sponsor category [1] 308140 0
None
Name [1] 308140 0
Address [1] 308140 0
Country [1] 308140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307545 0
Bellberry Pty Ltd
Ethics committee address [1] 307545 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 307545 0
Australia
Date submitted for ethics approval [1] 307545 0
09/12/2020
Approval date [1] 307545 0
11/03/2021
Ethics approval number [1] 307545 0
2020-12-1302

Summary
Brief summary
Alyra Biotech Pty Ltd is an Australian-owned biopharma company that wishes to develop an optimal intrauterine contraceptive device (IUCD) for young women with period or pelvic pain. We wish to determine the priorities of two end-user groups: women who may choose an IUCD for contraception or other health concerns, and Health Practitioners who advise women regarding the risks and benefits of IUCD use. Intrauterine devices are chosen as a form of contraception by 14% of women worldwide, with use of levonogestrel-releasing intrauterine devices increasing globally. However, some women experience increased pelvic pain in the 3-6 months after insertion. We wish to research the experiences, perspectives and preferences of both end-user groups to assist us in planning an optimal device for women with pain. The views and experiences of our end-user groups will guide our product development. Finally, to ensure that our product is commercially feasible, we wish to determine the cost premium that users, or prescribers, of the device would accept for such a device.

The primary objectives of this study are:
1. To determine the market potential for an intrauterine device that reduced pain in the first 3 months post-insertion by 50%.
2. To determine whether these women whether these women would be prepared to pay a price premium for such a device sufficient to justify device commercialisation.
3. To determine whether Health Practitioners who offer intrauterine contraceptive devices would prefer a device that reduced pain by 50% in the first 3 months post-insertion.
4. To investigate whether Health Practitioners believe their patients with dysmenorrhea or Chronic Pelvic Pain would pay a price premium for an IUCD that reduced post insertion pain compared with their patients who are pain free.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 107618 0
Dr Susan Evans
Address 107618 0
Alyra Biotech Pty Ltd
PO BOX 4025 Norwood South
SA, 5067
Country 107618 0
Australia
Phone 107618 0
+61 418 849 895
Fax 107618 0
Email 107618 0
susan.evans@alyrabiotech.com
Contact person for public queries
Name 107619 0
Mrs Rachael Tippett
Address 107619 0
Alyra Biotech Pty Ltd
PO BOX 4025 Norwood South
SA, 5067
Country 107619 0
Australia
Phone 107619 0
+61 414334583
Fax 107619 0
Email 107619 0
rachael.tippett@alyrabiotech.com
Contact person for scientific queries
Name 107620 0
Dr Susan Evans
Address 107620 0
Alyra Biotech Pty Ltd
PO BOX 4025 Norwood South
SA, 5067
Country 107620 0
Australia
Phone 107620 0
+61 418 849 895
Fax 107620 0
Email 107620 0
susan.evans@alyrabiotech.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study is for end user research and the privacy of the product must be maintained.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.