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

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ClinicalTrials.gov Identifier: NCT02545452
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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Study Type : Interventional  (Clinical Trial)
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 : September 15, 2015
Actual Primary Completion Date : March 14, 2016
Actual Study Completion Date : July 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: Tampons (3 changes per day) for 3 consecutive days




Primary Outcome Measures :
  1. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups [ Time Frame: 202-226h ]
  2. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups [ Time Frame: 226-298h ]
  3. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups [ Time Frame: 226-384h ]
  4. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group [ Time Frame: 466-490h ]
  5. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group [ Time Frame: 490-562h ]
  6. Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group [ Time Frame: 490-648h ]
  7. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups [ Time Frame: 202-226h ]
  8. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups [ Time Frame: 226-298h ]
  9. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups [ Time Frame: 226-384h ]
  10. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group [ Time Frame: 466-490h ]
  11. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group [ Time Frame: 490-562h ]
  12. Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group [ Time Frame: 490-648h ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration before co-medication or tampons (Cmax) [ Time Frame: 490h ]
  2. Time to reach maximum observed concentration before co-medication or tampons (tmax) [ Time Frame: 490h ]
  3. Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d)) [ Time Frame: 672h ]
  4. Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d)) [ Time Frame: 840h ]
  5. Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR) [ Time Frame: 672-840h ]
  6. Terminal half-life associated with the terminal slope after removal of IVR (t1/2) [ Time Frame: Up to 6 days after IVR removal ]
  7. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 14 days after IVR removal ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545452


Locations
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Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02545452     History of Changes
Other Study ID Numbers: 16997
2014-005167-32 ( EudraCT Number )
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Endometriosis
Genital Diseases, Female
Anti-Bacterial Agents
Antibiotics, Antitubercular
Miconazole
Anastrozole
Levonorgestrel
Nonoxynol
Spermatocidal Agents
Anti-Infective Agents
Antitubercular Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Protein Synthesis Inhibitors