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Serum cortisol in women users of subdermal levonorgestrel implants.

The aim of this study was to reveal changes in serum cortisol levels in users of subdermal levonorgestrel implants (Norplant). The study was undertaken on 18 regularly menstruating females subdermally implanted with 6 silastic rods, each containing 34 +or- 2 mg levonorgestrel, between days M0-M+4 of the menstrual cycle. Venous blood samples were collected between 10:00 and 11:00 a.m. under basal conditions, before and 1, 6, and 12 months after implantation. Sera were analyzed for cortisol by radioimmunoassay procedures. Mean +or- S.E.M. cortisol levels were 15.94 +or- 1.23, 10.20 +or- 0.84, 11.21 +or- 1.14, and 11.14 +or- 1.05 mcg prior to and 1, 6, and 12 months after implantation, respectively. All postimplantation values were significantly lower in comparison to basal levels. However, results obtained fell within the normal range of serum cortisol, with no subjects reporting symptoms of adrenocortical insufficiency.

Clinical Laboratory Techniques↗

Therapeutic use of tamoxifen in advanced breast cancer: correlation with biochemical parameters.

Tamoxifen (NSC-180973; ICI-46474) can provide palliation to patients with advanced breast cancer whose tumors contain estrogen-binding proteins (EBP). The drug is most effective in patients with bone metastasis and minimal prior therapy. In the present study, 72 patients with advanced breast cancer were evaluated for their response to oral tamoxifen therapy administered at a dose of 20 mg twice daily. Twenty-eight of 72 patients (38%) demonstrated objective responses to tamoxifen therapy. For patients with a positive EBP and no prior chemotherapy, eight of 11 (74%) responded. No patient possessing a tumor negative for EBP achieved a remission. Patients with tumors that possessed normal arylsulfatase B and glucose-6-phosphate dehydrogenase enzyme activities responded most favorably to tamoxifen therapy. These results demonstrate that tamoxifen is effective in the treatment of patients with advanced breast cancer, and EBP and specific enzymes might be useful in selecting the patients for hormone manipulation.

Adult↗

Levonorgestrel plasma levels during continuous administration with different models of subdermal implants.

Plasma concentrations of levonorgestrel were determined in women using subdermal levonorgestrel implants. One group had 6 Silastic capsules (NORPLANT), one group had 4 and one group had 6 covered Silastic rods for variable lengths of time. Levonorgestrel concentrations remained constant around 0.4 ng/ml up until 6 years of use in the Norplant group. The observation period was shorter for the covered rods; plasma concentrations were, however, constant around 0.55 ng/ml and 0.70 ng/ml for 3.5 years with the 4 rods and 6 covered rods, respectively. The difference in mean levonorgestrel concentrations between the three groups were statistically significant (p less than 0.0005). Plasma levels of levonorgestrel were twice to three times higher in blood obtained from the arm with the implants compared to the levels found in the other arm. The application of a tourniquet for variable periods before blood sampling did not influence the plasma concentrations of levonorgestrel.

Blood Specimen Collection↗

The relative bioavailability of levonorgestrel and ethinylestradiol when administered in tablet and capsule form.

The relative bioavailability of levonorgestrel (LNG) and ethinylestradiol (EE2) administered as a conventional tablet (150/30) or capsule has been assessed in a randomized two-period crossover study in 9 healthy volunteer women. Serum concentrations were monitored for 24h post-dosing. There was no significant difference in any of the pharmacokinetic parameters determined for either steroid. Hence the relative bioavailability is similar after tablet and capsule formulations.

Adolescent↗