A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

NCT00152282 | Completed Phase 2

• 1 other identifier: M00-198
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.

Conditions

Amenorrhea; Postmenopause

Keywords

Postmenopausal; Amenorrhea; Hormone replacement therapy; HRT; asoprisnil

Outcome Measures

Primary Outcomes (2)

• Assessment of endometrium by endometrial biopsy

  Week 12

• Change from baseline in endometrial thickness as assessed by ultrasound

  Week 12

Secondary Outcomes (4)

• Frequency and amount of vaginal bleeding via patient diary.

  Week 4, 8, and 12

• Incidence of hot flushes

  Week 4, 8, and 12

• Presence or absence of endometrial hyperplasia.

  Week 12

• Response to global efficacy question regarding improvement in menopause symptoms.

  Week 12

Study Arms (4)

1

EXPERIMENTAL

Drug: Asoprisnil/Premarin

2

EXPERIMENTAL

Drug: Asoprisnil/Premarin

3

EXPERIMENTAL

Drug: Asoprisnil/Premarin

4

PLACEBO COMPARATOR

Drug: Placebo and Premarin

Interventions

Asoprisnil/Premarin DRUG

Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

1

Placebo and Premarin DRUG

Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

4

Eligibility Criteria

• Age: 48 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women with an intact uterus
• Body mass index (BMI) between 18.0 - 33.0
• Good general health
• Endometrial thickness ≤ 4 mm by TVU
• No history or suspected endometrial hyperplasia
• Negative urine pregnancy test
• Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes
• Mammogram without suspicion of malignancy within last 6 months
• Endometrial biopsy with no evidence of pathologic changes within last 6 months

You may not qualify if:

• Any abnormal lab result the study-doctor considers significant
• History of severe reaction to hormone therapy
• Receiving hormone therapy
• Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones
• History or known or suspected cancer other than basal cell carcinoma
• Stenosis of the cervix
• History of reproductive endocrine disorder
• Washout requirement for hormonal therapy not met
• Ovarian mass
• Submucus or other symptomatic fibroid which would confound efficacy

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Amenorrhea

Interventions

asoprisnil; Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Medical Director

  Abbott

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: September 1, 2000
• Primary Completion: August 1, 2001
• Study Completion: August 1, 2001
• Last Updated: May 29, 2008

Record last verified: 2008-05