ContraceptionPhase 2INDessaNCT03562624
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
A Phase 2 study testing BAY98-7443 and Levonogestrel (Skyla, BAY86-5028) in people with Contraception, run by Bayer at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- BAY98-7443 and Levonogestrel (Skyla, BAY86-5028)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 22 Jun 2018to 1 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany6 sites
Dinox GmbH Berlin
Berlin, 10115
CRS Clinical Research Services Berlin GmbH
Berlin, 13353
Frauenarztpraxis Dr. Wetzel
Blankenburg, Saxony-Anhalt, 38889
CTC North GmbH & Co. KG
Hamburg, 20251
Praxis Hr. Dr. K. Peters
Hamburg, 22159
Nuvisan GmbH
Neu-Ulm, Bavaria, 89231
United Kingdom1 site
PAREXEL International Early Phase Clinical Unit (London)
Harrow, HA1 3UJ
About this study
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
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.
- Conditions
- Contraception
- Being tested
- BAY98-7443, Levonogestrel (Skyla, BAY86-5028)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY98-7443Drug
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)Drug
Also called Jaydess
Comparative LNG dose
| Study group | Role | What they receive |
|---|---|---|
| BAY98-7443 (low IND dose) | Experimental | Combi IUS Treatment, LNG (Levonorgestrel) with lowest dose of IND (indomethacin) Receives: Drug: BAY98-7443 |
| BAY98-7443 (middle IND dose) | Experimental | Combi IUS Treatment, LNG with medium dose of IND Receives: Drug: BAY98-7443 |
| BAY98-7443 (high IND dose) | Experimental | Combi IUS Treatment, LNG with highest dose of IND Receives: Drug: BAY98-7443 |
| Marketed comparator | Active comparator | Marketed comparator IUS Receives: Drug: Levonogestrel (Skyla, BAY86-5028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of uterine bleeding/spotting (B/S) days during treatment
Recorded by participants with electronic diary
Measured: 90 days after start of treatment
Secondary outcomes (2)
Number of subjects showing endometrial histology typical for intrauterine LNG application in biopsies taken at the end of treatment
Measured: On day 90 after start of treatment
Frequency of treatment emergent adverse events
Measured: 90 days after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start22 Jun 2018
- Primary completion16 May 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562624
- Sponsor's protocol ID
- 17700
- Other IDs
- 2018-000128-33, 2018
- Acronym
- INDessa
- Status last verified
- Aug 2019
- First submitted
- 8 Jun 2018
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hofmann BM, Ahola M, Fels LM, Klein S, Lindenthal B, Pihlaja J. Development of an Intrauterine Device Releasing Both Indomethacin and Levonorgestrel During the First Months of Use: Pharmacokinetic Characterization in Healthy Women. Clin Pharmacokinet. 2023 Jan;62(1):113-126. doi: 10.1007/s40262-022-01201-7. Epub 2023 Jan 17.
PubMed 36648744
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03562624
- Acronym / sponsor ID
- INDessa / 17700
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BAY98-7443 (low IND dose) | Experimental | Drug: BAY98-7443Combi IUS Treatment, LNG (Levonorgestrel) with lowest dose of IND (indomethacin) |
| BAY98-7443 (middle IND dose) | Experimental | Drug: BAY98-7443Combi IUS Treatment, LNG with medium dose of IND |
| BAY98-7443 (high IND dose) | Experimental | Drug: BAY98-7443Combi IUS Treatment, LNG with highest dose of IND |
| Marketed comparator | Active comparator | Drug: Levonogestrel (Skyla, BAY86-5028)Marketed comparator IUS |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY98-7443Active ingredient content (in mg IND/LNG): low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5 | Drug | BAY98-7443 (high IND dose), BAY98-7443 (low IND dose), BAY98-7443 (middle IND dose) |
| Levonogestrel (Skyla, BAY86-5028)Also: JaydessComparative LNG dose | Drug | Marketed comparator |
Primary outcome
Number of uterine bleeding/spotting (B/S) days during treatment
Time frame: 90 days after start of treatment
Recorded by participants with electronic diary
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Derived from this study: PubMed 36648744Hofmann BM, Ahola M, Fels LM, Klein S, Lindenthal B, Pihlaja J. Development of an Intrauterine Device Releasing Both Indomethacin and Levonorgestrel During the First Months of Use: Pharmacokinetic Characterization in Healthy Women. Clin Pharmacokinet. 2023 Jan;62(1):113-126. doi: 10.1007/s40262-022-01201-7. Epub 2023 Jan 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY98-7443 and Levonogestrel (Skyla, BAY86-5028) in people with Contraception, run by Bayer at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of uterine bleeding/spotting (B/S) days during treatment (time frame: 90 days after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.