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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02545452
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 4
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Anastrozole / Levonorgestrel (BAY98-7196); Drug: Gyno-Daktarin; Drug: Sobelin vaginal creme; Drug: Patentex oval; Other: Tampon	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Sep 15, 2015
• Actual Primary Completion Date: Mar 14, 2016
• Actual Study Completion Date: Jul 29, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BAY98-7196 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); Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG; Drug: Gyno-Daktarin; 400 mg miconazole nitrate per day for 3 consecutive days
Experimental: Administered Antibiotic 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); Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG; Drug: Sobelin vaginal creme; 100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
Experimental: Administered Spermicide 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); Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG; Drug: Patentex oval; 75 mg Nonoxynol-9 per day for 3 consecutive days
Experimental: Tampons 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); Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG; Other: Tampon; Other Names: Tampons (3 changes per day) for 3 consecutive days

Outcome Measures

Primary Outcome Measures

1. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups [202-226h]

2. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups [226-298h]

3. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups [226-384h]

4. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group [466-490h]

5. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group [490-562h]

6. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group [490-648h]

7. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups [202-226h]

8. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups [226-298h]

9. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups [226-384h]

10. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group [466-490h]

11. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group [490-562h]

12. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group [490-648h]

Secondary Outcome Measures

1. Maximum observed plasma concentration before co-medication or tampons (Cmax) [490h]

2. Time to reach maximum observed concentration before co-medication or tampons (tmax) [490h]

3. Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d)) [672h]

4. Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d)) [840h]

5. Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR) [672-840h]

6. Terminal half-life associated with the terminal slope after removal of IVR (t1/2) [Up to 6 days after IVR removal]

7. Number of participants with adverse events as a measure of safety and tolerability [Up to 14 days after IVR removal]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Berlin		Germany	13353

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02545452
• Other Study ID Numbers: 16997; 2014-005167-32
• First Posted: Sep 10, 2015
• Last Update Posted: Jul 24, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Endometriosis; Anastrozole; Levonorgestrel; Nonoxynol

Study Results

No Results Posted as of Jul 24, 2017