AzTrials
AzTrials

ContraceptionPhase 3NCT03074045

LCS16 vs. COC User Satisfaction and Tolerability Study

A Phase 3 study testing Levonorgestrel (Kyleena, BAY86-5028) and Ethinyl estradiol and drospirenone (Yarina, BAY86-5131) in people with Contraception, run by Bayer at 9 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months. Read more about this study

Who is it for?
Ages 18 to 29 years, women only
Conditions the study is for
Contraception
What is being tested?
Levonorgestrel (Kyleena, BAY86-5028) and Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
9 sitesRussia
Study dates
13 Mar 2017to 5 Aug 2022
Phase
Phase 3
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 29 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • The subject has signed and dated the Informed Consent Form (ICF).
  • The subject is healthy when requesting contraception.
  • The subject is between 18 - 29 years of age (inclusive) at the time of signing the ICF.
  • The subject has normal or clinically insignificant cervical smear for oncocytology (i.e. Pap test) not requiring further follow up (a cervical smear has to be taken at the Screening Visit [Visit 1] or a normal result has to have been documented within the previous 6 months).
  • The subject has a history of regular (i.e., endogenous cyclicity without hormonal contraceptive use) cyclic menstrual periods (length of cycle 21 - 35 days), as confirmed by the subject.
  • The subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Who cannot join

  • Pregnancy or current lactation (less than 6 weeks postpartum or since abortion before the Screening Visit)
  • Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit.
  • Chronic, daily use of drugs that may increase serum potassium levels.
  • Undiagnosed abnormal genital bleeding.
  • Acute cervicitis or vaginitis (until successfully treated).
  • Lower urinary tract infection (until successfully treated).
Show all 10Show fewer
  • Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections.
  • Congenital or acquired uterine anomaly including fibroids, in the opinion of the investigator, which would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity).
  • Cervical neoplasia, uterine or cervical malignancy, or sex hormone-dependent tumors.
  • History of migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Russia9 sites

  • Altai State Medical University

    Barnaul, 656038

  • Scientific Center of family health & human reprod. problems

    Irkutsk, 664003

  • Krasnoyarsk State Medical University

    Krasnoyarsk, 660022

  • City Clinical Hospital #13 Moscow

    Moscow, 115280

  • LLC Reafan

    Novosibirsk, 630099

  • Medical Center "Avicenna"

    Novosibirsk, 630099

  • LLC Medical center PRIME ROSE

    Saint Petersburg, 197374

  • Smolensk State Medical University

    Smolensk, 214019

  • Regional perinatal center

    Yaroslavl, 150042

Other trials in Russia

About this study

Official title: Multi-center, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 16 μg LNG/Day Initial in Vitro Release Rate (LCS16) in Comparison to a Combined Oral Contraceptive (COC) Containing 30 μg Ethinyl Estradiol and 3 mg Drospirenone (Yarina®) in Young Nulliparous and Parous Women (18 - 29 Years) Over 12 Months of Use (With an Option for Extended Use of LCS16 for up to 5 Years)

To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age [inclusive]), using LCS16 compared to a COC over a period of 12 months.

Conditions
Contraception
Being tested
Levonorgestrel (Kyleena, BAY86-5028), Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
Keywords
Intrauterine, Birth control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levonorgestrel (Kyleena, BAY86-5028)Drug

    Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years

  • Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)Drug

    COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months

Study groups in NCT03074045
Study groupRoleWhat they receive
TestExperimentalLCS16 (Low-dose LNG IUS)
Receives: Drug: Levonorgestrel (Kyleena, BAY86-5028)
ReferenceActive comparatorCOC (Yarina)
Receives: Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall satisfaction rate

    5-point Likert item

    1. Very satisfied
    2. Satisfied
    3. Neither satisfied nor dissatisfied
    4. Dissatisfied
    5. Very dissatisfied

    Measured: 12 months

Secondary outcomes (4)

  1. Number of adverse events

    at 1, 6 and 12 months for all subjects during the comparative part of the study.

    at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase.

    Measured: Up to 5 years

  2. Discontinuation rates

    at 1, 6 and 12 months for all subjects during the comparative part of the study.

    at the end of Year 2, Year 3, Year 4 and Year 5 only for subjects, who elect to enter the LCS16 extension phase.

    Measured: Up to 5 years

  3. Bleeding pattern

    Only during the comparative part of the study

    Measured: Up to 12 months

  4. User satisfaction and bleeding questionnaire

    At 6 and 12 months after the start of study treatment (or at early termination for those subjects discontinuing the study before completion of the 12 months) for all subjects during the comparative part of the study.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2017
  2. Study start13 Mar 2017
  3. Primary completion3 Sep 2018
  4. Study completion5 Aug 2022

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03074045
Sponsor's protocol ID
17878
Status last verified
Jun 2023
First submitted
3 Mar 2017
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Suturina L.V., Dikke G.B. Experience in the use of low-dosed levonorgestrelcontaining intrauterine system Kyleena LNG and combined oral contraceptive containing 30 mcg ethinyl estradiol and 3 mg drospirenone in young women. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2021; 11: 230-236 (in Russian)

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levonorgestrel (Kyleena, BAY86-5028) and Ethinyl estradiol and drospirenone (Yarina, BAY86-5131) in people with Contraception, run by Bayer at 9 sites in Russia.

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 6 inclusion and 10 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Russia. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall satisfaction rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03074045, which also lists 1 linked publication.

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 18 Jun 2023.

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