ContraceptionPhase 1NCT01595022
FR01 and FR20 IUS (Intrauterine System) Wearing Study
A Phase 1 study of Contraception, run by Bayer at 10 sites in 3 countries.
Trial summary
The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jan 2010to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Female subject
- Age 18-40 years (inclusive)
- History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
- Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
- Confirmed uterine sound depth of 6 to 10 cm
Who cannot join
- Pregnancy or lactation
- Sterilized
- Nulliparous
- Congenital or acquired uterine anomaly
- Vaginal or cesarean delivery within 8 weeks prior to insertion
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Finland4 sites
Study site
Helsinki, 00100
Study site
Kuopio, 70110
Study site
Tampere, 33100
Study site
Turku, 20100
Netherlands3 sites
Study site
Den Helder, 1780 AT
Study site
Heerlen, 6401 CX
Study site
Zwijndrecht, 3331 LZ
Sweden3 sites
Study site
Örebro, 701 85
Study site
Stockholm, 171 76
Study site
Uppsala, 75185
About this study
Official title: A Multi-center, Single-blinded, Randomized, Controlled, Parallel-group Study to Evaluate the Wearing Comfort of Two Different Placebo Intrauterine Systems FR01 and FR20 Compared to a Placebo T-frame Intrauterine System for 3 Cycles in Healthy Women Aged 18-40 Years
The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.
- Conditions
- Contraception
- Being tested
- Placebo: Flexi ring FR01, Placebo: Flexi ring FR20, Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo: Flexi ring FR01Drug
Intrauterine device, inserted once for 3 months
Placebo: Flexi ring FR20Drug
Intrauterine device, inserted once for 3 months
Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)Drug
Intrauterine device, inserted once for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Flexi ring FR01 | Placebo comparator | Not described Receives: Drug: Placebo: Flexi ring FR01 |
| Flexi ring FR20 | Placebo comparator | Not described Receives: Drug: Placebo: Flexi ring FR20 |
| Ultra low dose LCS | Placebo comparator | Not described Receives: Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595022
- Sponsor's protocol ID
- 13830
- Status last verified
- Apr 2015
- First submitted
- 8 May 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-blinded, Randomized, Controlled, Parallel-group Study to Evaluate the Wearing Comfort of Two Different Placebo Intrauterine Systems FR01 and FR20 Compared to a Placebo T-frame Intrauterine System for 3 Cycles in Healthy Women Aged 18-40 Years
- ClinicalTrials.gov ID
- NCT01595022
- Acronym / sponsor ID
- 13830
- Conditions
- Contraception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexi ring FR01 | Placebo comparator | Drug: Placebo: Flexi ring FR01 |
| Flexi ring FR20 | Placebo comparator | Drug: Placebo: Flexi ring FR20 |
| Ultra low dose LCS | Placebo comparator | Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Female subject
- Age 18-40 years (inclusive)
- History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
- Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
- Confirmed uterine sound depth of 6 to 10 cm
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Sterilized
- Nulliparous
- Congenital or acquired uterine anomaly
- Vaginal or cesarean delivery within 8 weeks prior to insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo: Flexi ring FR01Intrauterine device, inserted once for 3 months | Drug | Flexi ring FR01 |
| Placebo: Flexi ring FR20Intrauterine device, inserted once for 3 months | Drug | Flexi ring FR20 |
| Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)Intrauterine device, inserted once for 3 months | Drug | Ultra low dose LCS |
Primary outcome
Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Related trials for Contraception
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Contraception, run by Bayer at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Finland, Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.