Study Completed

Contraception

Bayer Identifier:

17700

ClinicalTrials.gov Identifier:

NCT03562624

EudraCT Number:

2018-000128-33

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years

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)

Trial summary

Enrollment Goal

174

Trial Dates

June 2018 - August 2019

Phase

Phase 2

Could I Receive a placebo

Products

Levonorgestrel and indomethacin (BAY98-7443)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical Research Services Berlin GmbH	Berlin, 13353, Germany
Completed	CTC North GmbH & Co. KG	Hamburg, 20251, Germany
Completed	Dinox GmbH Berlin	Berlin, 10115, Germany
Completed	Nuvisan GmbH	Neu-Ulm, 89231, Germany
Completed	PAREXEL International Early Phase Clinical Unit (London)	Harrow, HA1 3UJ, United Kingdom
Completed	Praxis Hr. Dr. K. Peters	Hamburg, 22159, Germany
Completed	Frauenarztpraxis Dr. Wetzel	Blankenburg, 38889, Germany
Withdrawn	Praxis f. Gynäkologie und Geburtshilfe	Bernburg, 06406, Germany

Primary Outcome

Number of uterine bleeding/spotting (B/S) days during treatment
Recorded by participants with electronic diary
Time Frame:
90 days after start of treatment

Secondary Outcome

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
Frequency of treatment emergent adverse events
Time Frame:
90 days after start of treatment

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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