A Phase 1 interventional study of Estriol 0.03 mg, lyophylized lactobacillus in Atrophic Vaginitis, sponsored by Medinova AG. Completed at 2 sites in 2 countries. Open to female participants aged 52 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Medinova AG · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the long term safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer patients who have been treated with aromatase inhibitors.
Two center phase I pharmacokinetic study assessed circulating estrogens in breast cancer patients on a non-steroidal aromatase inhibitor (NSAI) with vaginal atrophy using vaginal ultra-low-dose 0.03 mg estriol (E3) and Lactobacillus combination vaginal tablets (Gynoflor). 16 women on nonsteroidal aromatase inhibitor with severe vaginal atrophy applied a daily vaginal tablet of Gynoflor for 28 days followed by a maintenance therapy of 3 tablets weekly for 8 weeks.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's enrollment of 16 is below the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →Medinova AG is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gynoflor vaginal tablets 1/day x 4 weeks, then 3/week for 8 weeks
Drug: Estriol 0.03 mg, lyophylized lactobacillus
Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;
Also known as: Gynoflor
Serum Concentrations of Estriol (E3)
Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/). The lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).
Time frame: -0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28
Calculation of Pharmacokinetic Parameters Estriol: Cmax
Cmax is the highest measured concentration
Time frame: Days 0 and 28
Calculation of Pharmacokinetic Parameters Estriol: Tmax
Tmax is the peak time at which the Cmax (maximum concentration) was measured
Time frame: Days 0 and 28
Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)
Area under the curve from administration to the last measured concentration (AUC0-24)
Time frame: Days 0 and 28
Baseline / Trough Serum Concentrations of Estriol
Time frame: Days 0, 14, 28, 56 and 84
Vaginal pH
The normal vaginal pH is 3.8-5.0 pH is a logarithmic scale used to specify the acidity or basicity of aqueous solutions. The scale has values ranging from zero (the most acidic) to 14 (the most basic). Pure water has a pH value of 7. This value is considered neutral-neither acidic or basic.
Time frame: at all visits during 12 weeks
Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)
Time frame: Days 0, 14, 28, 56 and 84
Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)
Time frame: Days 0, 14, 28, 56 and 84
Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)
Time frame: Days 0, 14, 28, 56 and 84
| Milestone | Gynoflor |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/). The lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).
| pg/ml | Gynoflor |
|---|---|
| -0.5 h (Day 0) | 0 (0 to 0) |
| -0.5 h (Day 28) | 0.91 (0 to 14.5) |
| 0.5 h (Day 0) | 3.83 (0 to 14.10) |
| 0.5 h (Day 28) | 1.58 (0 to 12.90) |
| 1 h (Day 0) | 11.04 (0 to 18.8) |
| 1 h (Day 28) | 1.55 (0 to 14.40) |
| 2 h (Day 0) | 72.73 (0 to 168) |
| 2 h (Day 28) | 1.96 (0.00 to 16.60) |
| 3 h (Day 0) | 84.35 (0.00 to 160.00) |
| 3 h (Day 28) | 2.48 (0.00 to 29.20) |
| 4 h (Day 0) | 28.29 (0.00 to 67.50) |
| 4 h (Day 28) | 3.12 (0.00 to 37.70) |
| 6 h (Day 0) | 0.00 (0.00 to 0.00) |
| 6 h (Day 28) | 7.33 (0.00 to 39.50) |
| 8 h (Day 0) | 0.00 (0.00 to 0.00) |
| 8 h (Day 28) | 10.23 (0.00 to 43.70) |
| 24 h (Day 0) | 0.00 (0.00 to 0.00) |
| 24 h (Day 28) | 0.00 (0.00 to 0.00) |
Cmax is the highest measured concentration
| pg/ml | Gynoflor |
|---|---|
| Cmax (Day 0) | 104.5 ± 40.9 |
| Cmax (Day 28) | 15.8 ± 13.9 |
| pg/ml | Gynoflor |
|---|---|
| Estriol (Day 0) | 0.00 ± 0.00 |
| Estriol (Day 14) | 5.11 ± 14.01 |
| Estriol (Day 28) | 0.91 ± 3.63 |
| Estriol (Day 56) | 0.00 ± 0.00 |
| Estriol (Day 84) | 0.00 ± 0.00 |
The normal vaginal pH is 3.8-5.0 pH is a logarithmic scale used to specify the acidity or basicity of aqueous solutions. The scale has values ranging from zero (the most acidic) to 14 (the most basic). Pure water has a pH value of 7. This value is considered neutral-neither acidic or basic.
| pH | Gynoflor |
|---|---|
| Entry (Day 0) | 6.0 ± 0.3 |
| C1 (Day 14) | 4.6 ± 0.5 |
| C2 (Day 28) | 4.4 ± 0.4 |
| C3 (Day 56) | 4.6 ± 0.5 |
| C4 (Day 84) | 4.5 ± 0.5 |
Tmax is the peak time at which the Cmax (maximum concentration) was measured
| hours | Gynoflor |
|---|---|
| Tmax (Day 0) | 2.5 ± 0.5 |
| Tmax (Day 28) | 7.2 ± 1.5 |
Area under the curve from administration to the last measured concentration (AUC0-24)
| hours * pg/ml | Gynoflor |
|---|---|
| AUC (0-24h) (Day 0) | 212 ± 93.2 |
| AUC (0-24h) (Day 28) | 130.7 ± 147.2 |
| mIU/ml | Gynoflor |
|---|---|
| LH (Day 0) | 36.46 ± 11.05 |
| LH (Day 14) | 34.52 ± 12.18 |
| LH (Day 28) | 34.02 ± 12.68 |
| LH (Day 56) | 34.2 ± 49.87 |
| LH (Day 84) | 35.13 ± 10.34 |
| nmol/ml | Gynoflor |
|---|---|
| SHBG (Day 0) | 73.04 ± 29.66 |
| SHBG (Day 14) | 74.24 ± 35.35 |
| SHBG (Day 28) | 71.29 ± 31.88 |
| SHBG (Day 56) | 73.35 ± 32.76 |
| SHBG (Day 84) | 72.43 ± 34.57 |
| mIU/ml | Gynoflor |
|---|---|
| FSH (Day 0) | 107.88 ± 48.62 |
| FSH (Day 14) | 103.71 ± 39.76 |
| FSH (Day 28) | 98.94 ± 34.95 |
| FSH (Day 56) | 103.55 ± 37.53 |
| FSH (Day 84) | 105.93 ± 43.69 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gynoflor | 0/16 (0%) | 0/16 (0%) | 14/16 (87.5%) |
| Event | Gynoflor |
|---|---|
| Vaginal dischargeReproductive system and breast disorders | 5/16 |
| cystitisRenal and urinary disorders | 3/16 |
| Gastro-intestinal disordersGastrointestinal disorders | 3/16 |
| Influenza-like ilnessGeneral disorders | 2/16 |
| Ear and Labyrinth disordersEar and labyrinth disorders | 1/16 |
| Age, Continuous(years) | Gynoflor |
|---|---|
| Mean | 57 (52 to 63) |
| Sex: Female, Male(Participants) | Gynoflor |
|---|---|
| Female | 16 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Gynoflor |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Gynoflor |
|---|---|
| Belgium | 8 |
| Germany | 8 |
| Estriol(pg/ml) | Gynoflor |
|---|---|
| Mean | 104.5 ± 40.9 |
| Follicule Stimulating Hormone (FSH)(mIU/ml) | Gynoflor |
|---|---|
| Mean | 107.88 ± 48.62 |
| Luteinizing hormone (LH)(mIU/ml) | Gynoflor |
|---|---|
| Mean | 36.46 ± 11.05 |
| Sex hormone binding globulin (SHBG)(nmol/l) | Gynoflor |
|---|---|
| Mean | 73.04 ± 29.66 |
3 further baseline measures are reported on the registry.
The record gives a start of Apr 2011, a primary completion of Jul 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2024, 12 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Estriol
Medinova AG