Tibolone Endometrium Study (Study 32972)(P06470)

Postmenopausal Women Clinical Trial

— THEBES  

Official title:

A Multinational, Multicenter, Randomized, Double-blind, Parallel Group, Active Controlled, Comparative Trial, to Assess the Endometrial Histological Profile Following Treatment With Tibolone (Org OD14) Versus Conjugated Estrogen (CE) Plus Medroxyprogesterone Acetate (MPA) in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745108
• Other study ID #: P06470
• Secondary ID: 32972
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2001
• Est. completion date: July 21, 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 21, 2005
• Est. primary completion date: July 21, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive).

Exclusion Criteria:

• Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'.

• Double layer endometrial thickness > 6 mm as assessed by transvaginal ultrasonography (TVUS).

• Any previous or current unopposed estrogen administration or tamoxifen citrate.

• Any unexplained vaginal bleeding following the menopause.

• Women with abnormal Pap smear test results (PAP IIb and higher)

• Previous use of raloxifene hydrochloride for longer than one month.

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

Drug:
• tibolone
oral 1.25 mg tablet, once daily, for 2 years
• Tibolone 2.5 mg
oral 2.5 mg tablet, once daily, for 2 years
• CE/MPA
oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Archer DF, Hendrix S, Ferenczy A, Felix J, Gallagher JC, Rymer J, Skouby SO, den Hollander W, Stathopoulos V, Helmond FA; THEBES Study Group. Tibolone histology of the endometrium and breast endpoints study: design of the trial and endometrial histology at baseline in postmenopausal women. Fertil Steril. 2007 Oct;88(4):866-78. Epub 2007 Jun 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial biopsy and histological examination		At 1 year and 2 year.
Secondary	Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log.		TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording