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To Investigate the Pharmacological Effects, Drug Blood Levels and Safety of an Intrauterine System Releasing the Study Drug BAY1007626 in Comparison to Mirena and Jaydess in Healthy Young Women Treated for 90 Days to Determine the Drug Dose for Further Development

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: BAY1007626 (Drug); Jaydess (Drug); Mirena (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Summary

Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the drug dose for further development

Clinical Details

Official title: Multi-center, Randomized, Comparator-controlled, Single-blind, Parallel-group Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of an Intrauterine System Releasing BAY 1007626, as Compared With Mirena and Jaydess, in a Combined Proof-of-concept and Dose-finding Study in Healthy Pre Menopausal Women Treated for 90 Days

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Number of bleeding and spotting days

Progestin effects on endometrial histology

Ovulation(Yes/no)

Secondary outcome:

Endometrial thickness

Bleeding characterization (Intensity, pattern)

Serum levels of estradiol

Serum levels of progesterone

Serum levels of luteinizing hormone

Serum levels of follicle-stimulating hormone

Cervix function (Insler score)

Number of participants with adverse events as a measure of safety and tolerability.

Cmax of BAY1007626

AUC of BAY1007626

T1/2 of BAY1007626

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy female subject.

- Willingness to use non-hormonal methods of contraception during the study.

- This applies during the cycle preceding the pre-treatment cycle until the end of

follow-up.

- Age at screening: 18-40 years inclusive.

- Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m².

- History of regular cyclic menstrual periods.

- No clinically relevant abnormal findings in the pre-treatment endometrial biopsy.

Exclusion Criteria:

- Incompletely cured pre-existing diseases for which it can be assumed that the

absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.

- Any presence or history of known or suspected malignant tumors, especially any known

or suspected breast cancer or other progestin-sensitive cancer.

- Any presence or history of known or suspected benign tumors of the liver or of the

pituitary or adrenal gland.

- Amenorrhea (with unknown reason, not amenorrhea due to hormonal treatment) for more

than 3 months within the 6 months before the first screening examination.

- Use of short-acting preparations containing sex hormones during the cycle preceding

the pre-treatment cycle (oral, transdermal, intravaginal, IUS).

- Use of long-acting preparations containing sex hormones within the 40 weeks before

the first screening examination (any long-acting injectable or implant). Clinically relevant findings in the physical examination (e. g. pronounced varicosis, thrombophlebitis, and evidence of peripheral circulatory disturbances). Menstrual disorders with suspicion of ovarian failure (e. g., oligomenorrhea, amenorrhea, hypomenorrhea).

- Known bleeding irregularities

- Current or recurrent pelvic inflammatory disease, including pelvic inflammatory

disease within 6 month prior to the insertion of the IUS and any active sexually transmitted disease.

- Anovulatory pre-treatment cycle (ovulation has to be observed by day 27 at the

latest).

- Positive result of urine pregnancy test.

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Berlin 10115, Germany; Recruiting

Berlin 13353, Germany; Recruiting

Hamburg 22159, Germany; Not yet recruiting

Hamburg 22359, Germany; Not yet recruiting

Groningen 9713GZ, Netherlands; Recruiting

Belfast BT2 7BA, United Kingdom; Not yet recruiting

Hannover, Niedersachsen 30459, Germany; Not yet recruiting

Magdeburg, Sachsen-Anhalt 39126, Germany; Not yet recruiting

Additional Information

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Starting date: June 2015
Last updated: August 2, 2015

Page last updated: August 23, 2015

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