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

NCT02545452 | Completed Phase 1

• 2 other identifiers: 169972014-005167-32
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (12)

• Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups

  202-226h

• Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups

  226-298h

• Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups

  226-384h

• Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group

  466-490h

• Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group

  490-562h

• Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group

  490-648h

• Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups

  202-226h

• Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups

  226-298h

• Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups

  226-384h

• Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group

  466-490h

• Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group

  490-562h

• Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group

  490-648h

Secondary Outcomes (7)

• Maximum observed plasma concentration before co-medication or tampons (Cmax)

  490h

• Time to reach maximum observed concentration before co-medication or tampons (tmax)

  490h

• Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d))

  672h

• Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d))

  840h

• Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR)

  672-840h

Study Arms (4)

BAY98-7196

EXPERIMENTAL

Investigate the pharmacokinetics effect of a vaginally administered antimycotic (miconazole) during the use of an intra-vaginal ring (IVR) releasing anastrozole (ATZ) and levonorgestrel (LNG)

Drug: Anastrozole / Levonorgestrel (BAY98-7196); Drug: Gyno-Daktarin

Administered Antibiotic

EXPERIMENTAL

Investigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG

Drug: Anastrozole / Levonorgestrel (BAY98-7196); Drug: Sobelin vaginal creme

Administered Spermicide

EXPERIMENTAL

Investigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG

Drug: Anastrozole / Levonorgestrel (BAY98-7196); Drug: Patentex oval

Tampons

EXPERIMENTAL

Investigate the pharmacokinetics effect of the concomitant use of tampons during the use of an IVR releasing ATZ and LNG; investigate the pharmacokinetics over an extended IVR wearing period of 35 days

Drug: Anastrozole / Levonorgestrel (BAY98-7196); Other: Tampon

Interventions

Anastrozole / Levonorgestrel (BAY98-7196) DRUG

Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG

Administered Antibiotic; Administered Spermicide; BAY98-7196; Tampons

Gyno-Daktarin DRUG

400 mg miconazole nitrate per day for 3 consecutive days

BAY98-7196

Sobelin vaginal creme DRUG

100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days

Administered Antibiotic

Patentex oval DRUG

75 mg Nonoxynol-9 per day for 3 consecutive days

Administered Spermicide

Tampon OTHER

Also known as: Tampons (3 changes per day) for 3 consecutive days

Tampons

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Anastrozole; Levonorgestrel; Clotrimazole; Nonoxynol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Imidazoles; Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: September 15, 2015
• Primary Completion: March 14, 2016
• Study Completion: July 29, 2016
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

DE (1)