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Trial record 28 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

LCS16 vs. COC User Satisfaction and Tolerability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074045
Recruitment Status : Active, not recruiting
First Posted : March 8, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel (Kyleena, BAY86-5028) Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : September 3, 2018
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test
LCS16 (Low-dose LNG IUS)
Drug: Levonorgestrel (Kyleena, BAY86-5028)
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

Active Comparator: Reference
COC (Yarina)
Drug: Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)
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




Primary Outcome Measures :
  1. Overall satisfaction rate [ Time Frame: 12 months ]

    5-point Likert item

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


Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: Up to 5 years ]

    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.


  2. Discontinuation rates [ Time Frame: Up to 5 years ]

    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.


  3. Bleeding pattern [ Time Frame: Up to 12 months ]
    Only during the comparative part of the study

  4. User satisfaction and bleeding questionnaire [ Time Frame: Up to 12 months ]
    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.



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074045


Locations
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Russian Federation
Altai State Medical University
Barnaul, Russian Federation, 656038
Scientific Center of family health & human reprod. problems
Irkutsk, Russian Federation, 664003
Krasnoyarsk State Medical University
Krasnoyarsk, Russian Federation, 660022
City Clinical Hospital #13
Moscow, Russian Federation, 115280
LLC Reafan
Novosibirsk, Russian Federation, 630099
Medical Center "Avicenna"
Novosibirsk, Russian Federation, 630099
Smolensk State Medical University
Smolensk, Russian Federation, 214019
LLC Medical center PRIME ROSE
St. Petersburg, Russian Federation, 197374
Regional perinatal center
Yaroslavl, Russian Federation, 150042
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03074045     History of Changes
Other Study ID Numbers: 17878
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Intrauterine
Birth control
Additional relevant MeSH terms:
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Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Levonorgestrel
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents