AzTrials
AzTrials

EndometriosisPhase 1NCT02545452

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

A Phase 1 study testing Anastrozole / Levonorgestrel (BAY98-7196), Gyno-Daktarin and Sobelin vaginal creme in people with Endometriosis, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Endometriosis
What is being tested?
Anastrozole / Levonorgestrel (BAY98-7196), Gyno-Daktarin and Sobelin vaginal creme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteGermany
Study dates
15 Sep 2015to 29 Jul 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Study site

    Berlin, 13353

Other trials in Germany

About this study

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

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
Being tested
Anastrozole / Levonorgestrel (BAY98-7196), Gyno-Daktarin, Sobelin vaginal creme, Patentex oval, Tampon
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anastrozole / Levonorgestrel (BAY98-7196)Drug

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

  • Gyno-DaktarinDrug

    400 mg miconazole nitrate per day for 3 consecutive days

  • Sobelin vaginal cremeDrug

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

  • Patentex ovalDrug

    75 mg Nonoxynol-9 per day for 3 consecutive days

  • TamponOther

    Also called Tampons (3 changes per day) for 3 consecutive days

Study groups in NCT02545452
Study groupRoleWhat they receive
BAY98-7196ExperimentalInvestigate the pharmacokinetics effect of a vaginally administered antimycotic (miconazole) during the use of an intra-vaginal ring (IVR) releasing anastrozole (ATZ) and levonorgestrel (LNG)
Receives: Drug: Anastrozole / Levonorgestrel (BAY98-7196); Drug: Gyno-Daktarin
Administered AntibioticExperimentalInvestigate the pharmacokinetics effect of a vaginally administered antibiotic (clindamycin) during the use of an IVR releasing ATZ and LNG
Receives: Drug: Anastrozole / Levonorgestrel (BAY98-7196); Drug: Sobelin vaginal creme
Administered SpermicideExperimentalInvestigate the pharmacokinetics effect of a vaginally administered spermicide (nonoxynol-9) during the use of an IVR releasing ATZ and LNG
Receives: Drug: Anastrozole / Levonorgestrel (BAY98-7196); Drug: Patentex oval
TamponsExperimentalInvestigate 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
Receives: Drug: Anastrozole / Levonorgestrel (BAY98-7196); Other: Tampon

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 202-226h

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

    Measured: 226-298h

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

    Measured: 226-384h

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

    Measured: 466-490h

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

    Measured: 490-562h

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

    Measured: 490-648h

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

    Measured: 202-226h

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

    Measured: 226-298h

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

    Measured: 226-384h

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

    Measured: 466-490h

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

    Measured: 490-562h

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

    Measured: 490-648h

Secondary outcomes (7)

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

    Measured: 490h

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

    Measured: 490h

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

    Measured: 672h

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

    Measured: 840h

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

    Measured: 672-840h

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

    Measured: Up to 6 days after IVR removal

  7. Number of participants with adverse events as a measure of safety and tolerability

    Measured: Up to 14 days after IVR removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2015 (estimated)
  2. Study start15 Sep 2015
  3. Primary completion14 Mar 2016
  4. Study completion29 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545452
Sponsor's protocol ID
16997
Other IDs
2014-005167-32, 2014
Status last verified
Jul 2017
First submitted
8 Sep 2015
Last updated
24 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anastrozole / Levonorgestrel (BAY98-7196), Gyno-Daktarin and Sobelin vaginal creme in people with Endometriosis, run by Bayer at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups (time frame: 202-226h). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02545452.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.

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