A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best (AKRENDO1)

Bayer

Status and phase: Terminated; Phase 2

Conditions: Endometriosis

Treatments: Drug: Placebo; Drug: BAY1128688

Study type: Interventional

Funder types: Industry

Identifiers

NCT03373422

17472

2017-000244-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 6 patient groups, including a placebo group

BAY1128688 (dose 1)

Experimental group

Description:

One BAY1128688 tablet (lowest dose) in the morning, one placebo tablet in the evening

Treatment:

Drug: Placebo

Drug: BAY1128688

BAY1128688 (dose 2)

Experimental group

Description:

One BAY1128688 tablet (first intermediate dose) in the morning, one placebo tablet in the evening

Treatment:

Drug: Placebo

Drug: BAY1128688

BAY1128688 (dose 3)

Experimental group

Description:

One BAY1128688 tablet (second intermediate dose) in the morning, one placebo tablet in the evening

Treatment:

Drug: Placebo

Drug: BAY1128688

BAY1128688 (dose 4)

Experimental group

Description:

One BAY1128688 tablet (second intermediate dose) in the morning and one in the evening

Treatment:

Drug: BAY1128688

BAY1128688 (dose 5)

Experimental group

Description:

One BAY1128688 tablet (highest dose) in the morning and one in the evening

Treatment:

Drug: BAY1128688

Placebo

Placebo Comparator group

Description:

One placebo tablet in the morning and one in the evening

Treatment:

Drug: Placebo