A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women

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Abbott

Status and phase

Completed
Phase 2

Conditions

Postmenopause

Treatments

Drug: Asoprisnil/Premarin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00152295
M01-280

Details and patient eligibility

About

The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg

Full description

The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.

Enrollment

18 patients

Sex

Female

Ages

48 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Successful completion of study M00-198
  • Continued good general health
  • Negative urine pregnancy test

Exclusion criteria

  • History of known or suspected cancer other than basal cell carcinoma in last 5 years
  • History of reproductive endocrine disorder
  • Submucous or other symptomatic fibroid which would confound efficacy
  • Ovarian mass
  • Ongoing treatment with an excluded medication
  • Stenosis of the cervix
  • Any abnormal lab result the study-doctor considers significant.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Asoprisnil/Premarin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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