A double-blind, randomized, multi-center study to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation (0.5 mg 17b-estradiol [E2] / 0.25 mg drospirenone [DRSP]) and to compare the bleeding pattern of subjects treated with 0.5 mg E2 / 0.25 mg DRSP with the bleeding pattern of subjects treated with 1.0 mg E2 / 0.5 mg norethisterone acetate (NETA) when used for hormone therapy (HT) for 1 year in post-menopausal women - Angeliq low/low endometrial safety study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006199-39-AT

Enrollment

600

Registered

2007-04-23

Start date

2007-05-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women suffering from postmenopausal symptoms MedDRA version: 9.1 Level: LLT Classification code 10050903 Term: Postmenopausal symptoms

Interventions

Product Name: Angeliq low/low Product Code: SH K04739B Pharmaceutical Form: Capsule, hard INN or Proposed INN: Estradiol/Drospirenon Pharmaceutical form of the placebo: Capsule, hard Route of administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - postmenopausal women - non-hysterectomized women - symptoms requiring HT in the opinion of the investigator - endometrial biopsy at screening without evidence of endometrial hyperplasia or cancer. Women who have insufficient endometrial tissue for diagnosis may be included if a transvaginal ultrasound (TVUS) shows a double-walled endometrial thickness of =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - no endometrial biopsy available - usual HT exclusion criteria apply

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation. ;Secondary Objective: 1. The incidence of amenorrhea 2.The proportion of subjects with self-assessed symptoms of vulvar and vaginal atrophy and urogenital symptoms 3. The proportion of subjects with moderate to severe symptoms of vulvar and vaginal atrophy that have been identified by the subjects as being most bothersome to them 4. Women’s Health Questionnaire (WHQ) and the Clinical Global Impression (CGI) form 5. TVUS 6. Vital signs 7. General physical & gynecological examination (including cervical smear) 8. Mammography 9. Breast density analysis in a subgroup of subjects 10. Clinical laboratory evaluations 11. Reporting of (S)AEs and concomitant medication ;Primary end point(s): For the E2/DRSP group the proportion of subjects with an assessment of hyperplasia or worse during or after 13 cycles of treatment at Visit 5/EOS will be reported together with the exact two-sided 95% Clopper-Pearson confidence interval.	—

Measure

Time frame

Main Objective: The main objective is to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation. ;Secondary Objective: 1. The incidence of amenorrhea 2.The proportion of subjects with self-assessed symptoms of vulvar and vaginal atrophy and urogenital symptoms 3. The proportion of subjects with moderate to severe symptoms of vulvar and vaginal atrophy that have been identified by the subjects as being most bothersome to them 4. Women’s Health Questionnaire (WHQ) and the Clinical Global Impression (CGI) form 5. TVUS 6. Vital signs 7. General physical & gynecological examination (including cervical smear) 8. Mammography 9. Breast density analysis in a subgroup of subjects 10. Clinical laboratory evaluations 11. Reporting of (S)AEs and concomitant medication ;Primary end point(s): For the E2/DRSP group the proportion of subjects with an assessment of hyperplasia or worse during or after 13 cycles of treatment at Visit 5/EOS will be reported together with the exact two-sided 95% Clopper-Pearson confidence interval.

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Countries

Austria, Denmark, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026