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OpenTrials
Completed

NCT Number: NCT02545452

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

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

Completed

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anastrozole / Levonorgestrel (BAY98-7196)

Drug

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

Gyno-Daktarin

Drug

400 mg miconazole nitrate per day for 3 consecutive days

Sobelin vaginal creme

Drug

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

Patentex oval

Drug

75 mg Nonoxynol-9 per day for 3 consecutive days

Tampon

Other

Other names: Tampons (3 changes per day) for 3 consecutive days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2015
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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