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.

Phase 1

• Conditions: Contraception; MedDRA version: 20.0Level: LLTClassification code 10073728Term: Hormonal contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10010808Term: ContraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2018-000128-33-DE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-19
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 176

Inclusion Criteria

1. Signed and dated informed consent available before any study specific tests or procedures are performed
2. Healthy female subject
3. 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).
4. Age at screening: 18–45 years inclusive
5. Body mass index (BMI) at screening: = 18 and = 32 kg/m²
6. No clinically relevant abnormal findings in the pre-treatment endometrial biopsy
7. Adequate venous access (for frequent blood sampling)
8. The subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 176
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 pre-treatment 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, other allergic-type reactions, or known hypersensitivity reactions after local anesthetics, 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • The number of uterine bleeding and spotting days during the treatment period.;Secondary Objective: • Number of subjects showing endometrial histology typical for a levonorgestrel treatment <br>• Frequency of treatment emergent adverse events.<br>;Primary end point(s): Number of uterine bleeding/spotting (B/S) days during treatment (from Day 0 after insertion until the end of treatment on Day 89);Timepoint(s) of evaluation of this end point: Day 89

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Number of subjects showing endometrial histology typical for intrauterine application of LNG (assessment mainly based on criteria such as glandular architecture, glandular epithelium, gland secretion, gland mitosis, decidual changes to stroma) in biopsies taken during treatment <br>• Frequency of treatment- emergent adverse events <br>;Timepoint(s) of evaluation of this end point: Day 89