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

Contraception Clinical Trial

— INDessa  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562624
• Other study ID #: 17700
• Secondary ID: 2018-000128-33
• Status: Completed
• Phase: Phase 2
• Start date: June 22, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: August 1, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Contraception

Intervention

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
• Levonogestrel (Skyla, BAY86-5028)
Comparative LNG dose

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Berlin GmbH	Berlin
Germany	Dinox GmbH Berlin	Berlin
Germany	Frauenarztpraxis Dr. Wetzel	Blankenburg	Sachsen-Anhalt
Germany	CTC North GmbH & Co. KG	Hamburg
Germany	Praxis Hr. Dr. K. Peters	Hamburg
Germany	Nuvisan GmbH	Neu-Ulm	Bayern
United Kingdom	PAREXEL International Early Phase Clinical Unit (London)	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of uterine bleeding/spotting (B/S) days during treatment	Recorded by participants with electronic diary	90 days after start of treatment
Secondary	Number of subjects showing endometrial histology typical for intrauterine LNG application in biopsies taken at the end of treatment		On day 90 after start of treatment
Secondary	Frequency of treatment emergent adverse events		90 days after start of treatment