Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective: Explore the dose response relationship of different doses of
BAY 1128688 compared to placebo in the treatment of endometriosis-related
symptoms over a 12-week treatment period
Secondary outcome
Secondary objective: Assessment of safety and tolerability of BAY 1128688 over
a 12-week treatment period
Background summary
There is an unmet medical need for long term treatments of endometriosis, in
particular for treatments not impacting ovarian function and menstrual cycle.
Based on results in animal experiments it is hypothesized than the AKR1C3
inhibitor BAY1128688 may offer relief from pelvic pain (a key symptom of
patients with endometriosis) while not affecting ovarian function and menstrual
cycle. Study 17472 is the first clinical investigation testing the hypothesis
that administration of BAY1128688 translates into pain relief for patients with
endometriosis. Study 17472 will also expand the data base regarding safety and
tolerability of the AKR1C3 inhibitor BAY1128688.
Study objective
Purpose of the study is to test whether study drug BAY1128688 brings relief for
pain to women with endometriosis and if so to get a first impression which
dose(s) work best.
Study design
Randomized, placebo-controlled, double-blind, parallel-group, multi-center,
exploratory dose-response study
V1: Screening visit: eDiary completion. Eligibility check based on VAS (4 week
recall). First menstrual bleeding after V1. Screening period minimal 28 days
and maximum of 105 days.
V2: Randomization visit. Phone call. Pre-treatment period maximum 45 days.
V3: start of treatment. Treatment period is 12 weeks.
V4: week 1-2
V5: week 4
V6: week 8
V7: week 12 = end of treatment.
V8: End of Study, safety follow up 42 days, 6 weeks.
Intervention
Study medication. BAY 1128688. Two tablets per day: 1 in the morning and 1 in
the evening. There are 6 treatment arms.
3 mg, once daily + one placebo once daily
10 mg once daily + one placebo once daily
30 mg once daily + one placebo once daily
30 mg twice daily
60 mg twice daily
Reference drug: Placebo
Study burden and risks
Expected benefit: Health of participants will be monitored carefully. All study
related visits to the study clinic and study assessments are free of charge.
Benefit with regard to relief from administration of BAY1128688 is expected but
uncertain. Risks: described in the patient information
Burden: The study consists of 7 site visits and one phone call visit. Visits
comprise gynecological investigation and transvaginal ultrasound and blood
drawings at each visit.
Participants will complete electronic hand held diary each day, during the
whole duration of the study. Daily burden is estimated to be about 5 minutes.
Energieweg 1
Mijdrecht 3641 RT
NL
Energieweg 1
Mijdrecht 3641 RT
NL
Listed location countries
Age
Inclusion criteria
- Women of at least 18 years of age at the time of signing of informed consent.
- Women with endometriosis confirmed by at least one of the two criteria:
-- surgery within the last 10 years
-- imaging within the last 12 months
- moderate to severe pelvic pain which will be assessed over a period of 28 days
- Willingness to use only ibuprofen as rescue pain medication for endometriosis-associated pelvic pain.
- Willingness to use non-hormonal barrier method for contraception (here spermicide-coated condoms) from screening visit until the end of the study (unless adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device [IUD] or commitment to
abstinence) and to refrain from using hormonal contraception.
Exclusion criteria
- Pregnancy or lactation (more than three months since delivery, abortion, or lactation before start of treatment) AND no wish for pregnancy during the study.
- Altered bilirubin metabolism and liver function at Visit 1.
- Requirement to use pain medications for reasons other than endometriosis.
- Contraindications to using ibuprofen.
- Signs of hyperandrogenism.
- Absence of menstrual cycles and/or abnormal vaginal/genital bleeding
- History of hysterectomy, tubal-ligation or bilateral ovariectomy
- Uncontrolled thyroid disorder
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-000244-18-NL |
| CCMO | NL62761.100.17 |