A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indom… (NCT03562624) | Clinical Trial Compass
CompletedPhase 2
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
Germany177 participantsStarted 2018-06-22
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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…
What they're measuring
1
Number of uterine bleeding/spotting (B/S) days during treatment