Effect of Concomitant Use of an Antimycotic, an Antibiotic, a Spermicide or Tampons on Pharmacokinetics of Anastrozole and Levonorgestrel Released From Intra-vaginal Ring

Endometriosis Clinical Trial

Official title:

A Parallel Group, Randomized, Open-label Study to Investigate the Effect of the Intravaginally Administered Antimycotic Miconazole, Antibiotic Clindamycin, Spermicide Nonoxynol-9, or Co-usage of Tampons on 3 Consecutive Days on the Pharmacokinetics of Anastrozole and Levonorgestrel Released From an Intra-vaginal Ring in Healthy Young Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545452
• Other study ID #: 16997
• Secondary ID: 2014-005167-32
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2015
• Last updated: July 21, 2017
• Start date: September 15, 2015
• Est. completion date: July 29, 2016

Study information

• Verified date: July 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the pharmacokinetic effect of a vaginally administered antimycotic (miconazole), antibiotic (clindamycin), spermicide (nonoxynol-9) or the concomitant use of tampons during the use of an intravaginal ring releasing anastrozole and levonorgestrel

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 29, 2016
• Est. primary completion date: March 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy pre-menopausal female subject.

• Age: 18 - 50 years (inclusive) at the first screening visit. For the subject > 45 years follicle stimulating hormone (FSH) will be investigated at the second screening visit to confirm the pre-menopausal status (FSH < 40 IU/L in serum).

• Body mass index (BMI ) above or equal 18, and below or equal 30 kg / m² at the first screening visit.

• Adequate venous access.

• Ability to understand and follow study-related instructions

• Agreement to use adequate non-hormonal contraception.

• Confirmation of the subject's health insurance coverage prior to the first screening examination/visit.

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.

• Thrombophlebitis, venous / arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction).

• Presence or history of prodromata of thrombosis (e.g. transient ischemic attack, angina pectoris).

• Known hypersensitivity to the study medications (active substances or excipients of the preparations).

• Regular intake of medication other than hormonal contraceptives.

• Use of systemic or topical medication or substances which oppose the study objectives or which might influence them within 4 weeks before first administration of the study medication,

• Smoking of more than 10 cigarettes daily; if the subject is a smoker: subject is older than 35 years

• Suspicion of or known current drug, medicine or alcohol abuse (including anabolics, high-dose vitamins).

• Abnormal cervical smear

• Previous ectopic pregnancy.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Anastrozole / Levonorgestrel (BAY98-7196)
Release rate of the IVR: 1050 µg/d ATZ + 40 µg/d LNG
• Gyno-Daktarin
400 mg miconazole nitrate per day for 3 consecutive days
• Sobelin vaginal creme
100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
• Patentex oval
75 mg Nonoxynol-9 per day for 3 consecutive days

Other:
• Tampon

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups		202-226h
Primary	Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups		226-298h
Primary	Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups		226-384h
Primary	Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group		466-490h
Primary	Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group		490-562h
Primary	Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group		490-648h
Primary	Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups		202-226h
Primary	Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups		226-298h
Primary	Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups		226-384h
Primary	Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group		466-490h
Primary	Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group		490-562h
Primary	Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group		490-648h
Secondary	Maximum observed plasma concentration before co-medication or tampons (Cmax)		490h
Secondary	Time to reach maximum observed concentration before co-medication or tampons (tmax)		490h
Secondary	Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d))		672h
Secondary	Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d))		840h
Secondary	Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR)		672-840h
Secondary	Terminal half-life associated with the terminal slope after removal of IVR (t1/2)		Up to 6 days after IVR removal
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 14 days after IVR removal

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