- « Previous
- Clinical Pharmacology
- Next »
Prometrium
Clinical Pharmacology
Prometrium
The times to diagnosis of endometrial hyperplasia over 36 months of treatment are shown in Figure 1. This figure illustrates graphically that the proportion of patients with hyperplasia was significantly greater for the conjugated estrogens group (64%) compared to the conjugated estrogens plus PROMETRIUM Capsules group (6%).
Figure 1
 |
The discontinuation rates due to hyperplasia over the 36 months of treatment are as shown in Table 4. For any degree of hyperplasia, the discontinuation rate for patients who received conjugated estrogens plus PROMETRIUM Capsules was similar to that of the placebo only group, while the discontinuation rate for patients who received conjugated estrogens alone was significantly higher. Women who permanently discontinued treatment due to hyperplasia were similar in demographics to the overall study population.
TABLE 4
Discontinuation Rate Due to Hyperplasia Over 36 Months of Treatment
| Most Advanced Biopsy Result Through 36 Months of Treatment | Treatment Group | |||||
| Conjugated Estrogens +PROMETRIUM Capsules(cyclical) | Conjugated Estrogens (only) | Placebo | ||||
| N=120 | N=119 | N=119 | ||||
| Number of patients | % of patients | Number of patients | % of patients | Number of patients | % of patients | |
| Adenocarcinoma | 0 | 0 | 0 | 0 | 1 | 1 |
| Atypical hyperplasia | 1 | 1 | 10 | 8 | 0 | 0 |
| Complex hyperplasia | 0 | 0 | 21 | 18 | 1 | 1 |
| Simple hyperplasia | 1 | 1 | 13 | 11 | 0 | 0 |
In the same 3-year clinical trial, postmenopausal women were treated with PROMETRIUM Capsules in combination with conjugated estrogens, conjugated estrogens only, or placebo. There was no statistically significant difference between the PROMETRIUM Capsules plus conjugated estrogens group and the conjugated estrogens only group in increases of HDL-C and triglycerides, or in decreases of LDL-C. The changes observed in lipid profiles are shown in Table 5.
TABLE 5
Mean Changes from Baseline in Lipid Profiles After 36 Months of Treatment
| Parameter | Treatment Group Mean (Mean % Change) | |||||
| Conjugated Estrogens0.625 mg +PROMETRIUMCapsules 200 mg(cyclical)a | Conjugated Estrogens 0.625 mg (only) | Placebo | ||||
| N= 176 to 177b | N=171 to 173b | N=171 | ||||
| Mean Change | Mean % Change | Mean Change | Mean % Change | Mean Change | Mean % Change | |
| LIPID PROFILE | ||||||
| HDL-C(mmol/L) | 0.07 | 5.1 | 0.10 | 7.2 | -0.05 | -2 |
| LDL-C(mmol/L) | -0.43 | -11.8 | -0.36 | -9.5 | -0.14 | -2.9 |
| Cholesterol (mmol/L) | -0.26 | -4.0 | -0.22 | -3.6 | -0.15 | -1.8 |
| Triglyceride (mmol/L)c | 0.20 | 17.8 | 0.15 | 13.7 | 0.01 | 0.6 |
| a There are no significant changes
(p<0.05) from conjugated estrogens values. b Number of subjects (N) varies by parameter. c Computed from log transformed data. |
||||||
Generic Name: Progesterone
- « Previous
- Clinical Pharmacology
- Next »
Women's Health
Find out what women really need.
3D Mammogram
Learn how new technology may change the way breast cancer is diagnosed and in turn, save more lives. See more WebMD Videos »
ENABLEX is a prescription medicine used in adults to treat the following symptoms due to a condition called overactive bladder:
- · having a strong need to go to the bathroom right away (also called "urgency")
- · leaks or wetting accidents (also called "urinary incontinence")
- · having to go to the bathroom too often (also called "urinary frequency")
IMPORTANT SAFETY INFORMATION
You should not take once-daily ENABLEX if you have certain types of stomach problems, glaucoma, or have trouble emptying your bladder. Side effects of ENBLEX include blurred vision, and more commonly dry mouth, constipation, indigestion, and abdominal pain. Use caution when doing certain activities until you know how ENBALEX affects you.
Prometrium
Health Resources
2008 Election & Health Care on WebMD. Get Informed.
Updated & New
RxList does not provide medical advice, diagnosis or treatment.