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A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components (INDessa)

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ClinicalTrials.gov Identifier: NCT03562624
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
This study is the first study investigating the combined intrauterine administration of LNG (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose finding (DF) study in pre-menopausal women. It is designed to investigate the pharmacodynamics (PD) of BAY 987443 (i.e. IUS (intrauterine system) releasing LNG and IND), as well as pharmacokinetics (PK) of both active substances, safety and tolerability. In this study, Jaydess, as an LNG-only IUS, will be used as a comparator.

Condition or disease Intervention/treatment Phase
Contraception Drug: BAY98-7443 Drug: Levonogestrel (Skyla, BAY86-5028) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Comparator-controlled, Single-blind, Parallel-Group Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of an Intrauterine System (BAY987443) With Three Different Release Rates of Indomethacin and One Release Rate of Levonorgestrel, as Compared With Jaydess, in a Combined Proof-of-concept and Dose Finding Study in Healthy Pre-menopausal Women Treated for 90 Days
Actual Study Start Date : June 22, 2018
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : August 1, 2019

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Arm Intervention/treatment
Experimental: BAY98-7443 (low IND dose)
Combi IUS Treatment, LNG (Levonorgestrel) with lowest dose of IND (indomethacin)
Drug: BAY98-7443

Active ingredient content (in mg IND/LNG):

low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5


Experimental: BAY98-7443 (middle IND dose)
Combi IUS Treatment, LNG with medium dose of IND
Drug: BAY98-7443

Active ingredient content (in mg IND/LNG):

low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5


Experimental: BAY98-7443 (high IND dose)
Combi IUS Treatment, LNG with highest dose of IND
Drug: BAY98-7443

Active ingredient content (in mg IND/LNG):

low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5


Active Comparator: Marketed comparator
Marketed comparator IUS
Drug: Levonogestrel (Skyla, BAY86-5028)
Comparative LNG dose
Other Name: Jaydess




Primary Outcome Measures :
  1. Number of uterine bleeding/spotting (B/S) days during treatment [ Time Frame: 90 days after start of treatment ]
    Recorded by participants with electronic diary


Secondary Outcome Measures :
  1. Number of subjects showing endometrial histology typical for intrauterine LNG application in biopsies taken at the end of treatment [ Time Frame: On day 90 after start of treatment ]
  2. Frequency of treatment emergent adverse events [ Time Frame: 90 days after start of treatment ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agreement to use an acceptable non-hormonal method of contraception (i.e. male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide) when sexually active. This applies during the pre-treatment cycle and directly following the treatment period until the end of the follow-up period. This is not required if safe contraception is achieved by a permanent method, such as bilateral fallopian tube blockage of the subject or vasectomy of the partner(s).
  • Age at screening: 18-45 years inclusive
  • Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
  • No clinically relevant abnormal findings in the pre-treatment endometrial biopsy
  • Adequate venous access (for frequent blood sampling)

Exclusion Criteria:

  • Menstrual disorders with unknown reason (not e.g. oligomenorrhea, hypomenorrhea amenorrhea due to hormonal treatment; not irregularities occurring during menarche). In case it is suspected that the woman is peri-menopausal, she should be excluded.
  • Use of short-acting hormonal contraceptives/preparations containing sex hormones (oral, transdermal, intravaginal, IUS) during the pretreatment cycle
  • Use of long-acting preparations containing sex hormones within the 40 weeks before the first screening examination (any long-acting injectable or implant)
  • History of known or presence of suspected or known malignant tumors, especially any breast cancer, cervical carcinoma in situ or other progestin-sensitive cancer
  • History of skin reactions, or other allergic-type reactions or known hypersensitivity reactions after taking aspirin, IND or other NSAIDs or to LNG, or any excipients of the IUSs
  • Regular use of corticosteroids, irrespective of route of administration
  • Known asthma bronchiale and aspirin-sensitive asthma
  • Current or recurrent pelvic inflammatory disease
  • Abnormal cervical smear within the last 6 month prior to screening
  • Acute genital infection
  • Known current thyroid disorders which require treatment (subjects with an euthyroid struma who do not need any treatment can participate)

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): NCT03562624


Locations
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Germany
Nuvisan GmbH
Neu-Ulm, Bayern, Germany, 89231
Frauenarztpraxis Dr. Wetzel
Blankenburg, Sachsen-Anhalt, Germany, 38889
Dinox GmbH Berlin
Berlin, Germany, 10115
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
CTC North GmbH & Co. KG
Hamburg, Germany, 20251
Praxis Hr. Dr. K. Peters
Hamburg, Germany, 22159
United Kingdom
PAREXEL International Early Phase Clinical Unit (London)
Harrow, United Kingdom, HA1 3UJ
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: NCT03562624     History of Changes
Other Study ID Numbers: 17700
2018-000128-33 ( EudraCT Number )
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Levonorgestrel
Indomethacin
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action