NCT02413008 (BLISSAFE) is a Phase 2 clinical trial of estriol in Vaginal Atrophy, sponsored by ITF Research Pharma, S.L.U..

Who is sponsoring NCT02413008?

NCT02413008 is sponsored by ITF Research Pharma, S.L.U..

What drugs are being tested in NCT02413008?

Interventions in NCT02413008: estriol, Placebo.

What condition does NCT02413008 study?

NCT02413008 studies Vaginal Atrophy.

Is NCT02413008 still recruiting?

NCT02413008 is currently completed. Last updated 5 August 2019.

Are results published for NCT02413008?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-05 · How we verify

NCT02413008: BLISSAFE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting

Completed Phase 2 Results posted Last updated 5 August 2019

What this trial tests

Phase 2 trial testing estriol in Vaginal Atrophy in 61 participants. Completed in 10 February 2017.

Timeline

16 October 2015

Primary endpoint
10 February 2017

10 February 2017

Quick facts

Lead sponsor	ITF Research Pharma, S.L.U.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	61
Start date	16 October 2015
Primary completion	10 February 2017
Estimated completion	10 February 2017
Sites	6 locations across Sweden, Spain

Drugs / interventions tested

estriol (ESTRIOL) — full drug profile →
Placebo

Conditions studied

Vaginal Atrophy — all drugs for Vaginal Atrophy →

Sponsor

ITF Research Pharma, S.L.U.

Who can join

Eligibility, female only, with Vaginal Atrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Variation in Serum Levels of Follicle Stimulating Hormone (FSH) Primary · from baseline to 12 weeks of treatment

Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-2.8	-13.1 – 7.4
Placebo Vaginal Gel	1.4	-5.4 – 15.7

Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8 Secondary · Change from baseline to week 1, week 3 and week 8

Change from Baseline (mean screening-baseline) to Week 1, Week 3 and Week 8 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability ( screening-baseline variation)

change from baseline to week 1

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-4.8	-11.6 – 2.6
Placebo Vaginal Gel	4.2	-7.8 – 7.3

change from baseline to week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-4.2	-12.0 – 3.5
Placebo Vaginal Gel	-0.9	-4.0 – 2.3

change from baseline to week 8

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-2.6	-10.1 – 7.9
Placebo Vaginal Gel	5.2	-11.8 – 9

Variation in Serum Levels of Luteinizing Hormone (LH) Secondary · Change from baseline to week 1, week 3, week 8 and week 12

Change from (mean screening-baseline) in plasma levels of LH to Week 1, Week 3, Week 8 and Week 12 in Serum Levels of LH compare to natural physiological variability ( screening-baseline variation)

change from LH baseline to week 1

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-0.6	-3.7 – 2.8
Placebo Vaginal Gel	0.2	-1.8 – 8.1

change from LH baseline to week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-0.5	-4.1 – 3.5
Placebo Vaginal Gel	0.3	-1.8 – 7.7

change from LH baseline to week 8

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-0.3	-4.9 – 3.1
Placebo Vaginal Gel	-1.3	-2.0 – 6.0

change from LH baseline to week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-0.8	-5.3 – 2.9
Placebo Vaginal Gel	1.3	-1.6 – 7.1

Variation in Plasma Levels of Estriol Secondary · Change from baseline to week 1, week 3, week 8 and week 12

Change in plasma levels of estriol at weeks 1, 3, 8 and 12 compared to baseline

Change between baseline and week 1

Group	Value	95% CI
0.005% Estriol Vaginal Gel	-1.7	-10.7 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

Change between baseline and week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	-3.4 – 0.5
Placebo Vaginal Gel	0.0	0.0 – 0.0

Change between baseline and week 8

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	-5.0 – 0.5
Placebo Vaginal Gel	0.0	0.0 – 0.0

Change between baseline and week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	-6.8 – 0.5
Placebo Vaginal Gel	0.0	0.0 – 0.0

Variation in Plasma Levels of Estradiol Secondary · Change from baseline to week 1, week 3, week 8 and week 12

Change in plasma levels of estradiol at weeks 1, 3, 8 and 12 compared to baseline.

Change between baseline and week 1

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

Change between baseline and week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

Change between baseline and week 8

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

Change between baseline and week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

Variation in Plasma Levels of Estrona Secondary · Change from baseline to week 1, week 3, week 8 and week 12

Change in plasma levels of estrona at weeks 1, 3, 8 and 12 compared to baseline.

Change from baseline to week 1

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

Change between baseline and week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

change from baseline to week 8

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

Change from baseline to week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 0.0
Placebo Vaginal Gel	0.0	0.0 – 0.0

Changes in Vaginal pH Between Baseline and Week 3 and Week 12 Secondary · week 3 and week 12 vs baseline

Measurement of vaginal pH on the vaginal secretion using a reactive strip and compare pH value between baseline and the diferent timepoints

Change from baseline to Week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	2.0	0.5 – 2.5
Placebo Vaginal Gel	0.5	-0.5 – 1.0

Change from baseline to Week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	1.3	0.5 – 2.5
Placebo Vaginal Gel	0.5	0.0 – 1.5

Changes in Dyspareunia Secondary · week 3 and week 12 vs baseline

Changes in dyspareunia from baseline to week 3 and week 12 Each symptom will be scored in a numeric scale from 0 to 3, as shown 0 Absence. The symptom is not present 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient 3. The symptom is stated as very irritating and severe in intensity

Change between baseline and week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	1.0	1.0 – 2.0
Placebo Vaginal Gel	1.0	0.0 – 1.0

Change between baseline and week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	2.0	1.0 – 2.5
Placebo Vaginal Gel	1.0	0.0 – 2.0

Change in Pruritus or Itching From Baseline to Week 3 and Week 12 Secondary · Change from baseline to week 3 and week 12

Change in pruritus or itching from baseline to week 3 and week 12 Each symptom will be scored in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient 3. The symptom is stated as very irritating and severe in intensity

Changes between baseline and week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 1.0
Placebo Vaginal Gel	0.0	-1.0 – 2.0

Changes between baseline and week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	0.0	0.0 – 2.0
Placebo Vaginal Gel	0.0	0.0 – 1.0

Changes in Vaginal Dryness Secondary · week 3 and week 12 vs baseline

Change in vaginal dryness puntuation score from baseline to w3 and w12 Each symptom will be scored in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient 3. The symptom is stated as very irritating and severe in intensity

Change between baseline and week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	1.0	1.0 – 2.0
Placebo Vaginal Gel	1.0	0.0 – 1.0

Change between baseline and week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	2.0	1.0 – 2.0
Placebo Vaginal Gel	1.0	1.0 – 1.0

Changes in Total Score of Symptoms of Vaginal Atrophy Secondary · week 3 and week 12 vs baseline

Changes in Symptoms of vaginal atrophy (vaginal dryness, dyspareunia and pruritus) at week 3 and week 12 vs baseline. Each symptom will be scored in a numeric scale from 0 to 3, as shown below: 0 Absence. The symptom is not present 1. The symptom is of mild intensity, without interfering in the patient's activity 2. The symptom is of moderate intensity, causing obvious discomfort to the patient 3. The symptom is stated as very irritating and severe in intensity A Global Symptoms Score will be calculated by summing the intensities of all the three symptoms of vaginal atrophy in a certain tim

Change between baseline and week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	3.0	2.0 – 4.5
Placebo Vaginal Gel	1.0	0.5 – 3.0

Change between baseline and week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	4.5	3.0 – 7.0
Placebo Vaginal Gel	2.0	1.5 – 4.0

Changes in Dryness of the Mucosa Secondary · week 3 and week 12 vs baseline

It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows: 0 Absence. The sign is not present. 1. The sign is present and is considered a mild alteration 2. The sign is present and is considered a moderate alteration 3. The sign is present and is considered a severe alteration

Changes between baseline and week 3

Group	Value	95% CI
0.005% Estriol Vaginal Gel	2.0	1.0 – 2.0
Placebo Vaginal Gel	1.0	0.0 – 1.0

Changes between baseline and week 12

Group	Value	95% CI
0.005% Estriol Vaginal Gel	2.0	1.0 – 2.0
Placebo Vaginal Gel	1.0	0.0 – 1.0

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline to last visit (up to 16 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

0.005% Estriol Vaginal Gel

Serious: 1/50 (2%)

Deaths: 0/50

Placebo Vaginal Gel

Serious: 0/11 (0%)

Deaths: 0/11

Serious adverse events (1 terms)

Reaction	System	0.005% Estriol Vaginal Gel	Placebo Vaginal Gel
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	0.005% Estriol Vaginal Gel	Placebo Vaginal Gel
Urinary tract infection	Infections and infestations	—	—

Most-reported serious reactions: Lymphoma.

Data from ClinicalTrials.gov NCT02413008 adverse events section.

Sponsor's own description

This is a phase II, prospective, randomized, double-blind, placebo-controlled, international (Spain and Sweden) and multicentre study to explore the safety of 0.005% estriol vaginal gel in women with early stage breast cancer in treatment with Non-Steroidal Aromatase Inhibitors (NSAIs) in the adjuvant setting and symptoms of vaginal atrophy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Phase II Prospective, Randomized, Double-Blind, Placebo-Controlled and Multicenter Clinical Trial to Assess the Safety of 0.005% Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women with Early Stage Breast Cancer in Treatment with Aromatase Inhibitor in the Adj
Sánchez-Rovira P, Hirschberg AL, Gil-Gil M, Bermejo-De Las Heras B, et al · · 2020 · cited 24× · PMID 32459035 · DOI 10.1634/theoncologist.2020-0417

Verify or expand the search:

Other recruiting trials for Vaginal Atrophy

Currently open trials in the same condition.

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NCT06028009 — PRP Injections for Genitourinary Syndrome of Menopause · NA · active not recruiting
NCT07024667 — Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vagin · NA · recruiting
NCT05335317 — Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser · NA · recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02413008 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ITF Research Pharma, S.L.U.
Last refreshed: 5 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02413008.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02413008: BLISSAFE

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Vaginal Atrophy

Verify against primary sources