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Abstract
Long-acting, biodegradable, subcutaneous implants of fused pellets composed of norethindrone
(NET) and pure cholestrol were evaluated in 50 healthy, normally menstruating volunteers
from five clinics. Evaluation of serum NET levels indicated a steady release rate
over the 6-cycle follow-up period. There were no serious local reactions to the pellets.
Menstrual cycle length remained unchanged, but the incidence of intermenstrual bleeding
and/or spotting was higher during the initial 2–3 months of pellet use. Following
pellet removal menstrual cycle parameters returned to their pre-pellet implantation
values. Serum gonadotropin assays indicated the incidence of ovulatory cycles increased
over the follow-up period. No significant changes in serum lipoproteins, SMAC-12 or
enzyme profiles were observed. Although women were advised to use additional methods
of contraception, three became pregnant while using the implants. Fibrous tissue was
noted to form around the pellets, thus limiting the release of NET. Additional trials
of higher NET doses are being evaluated.
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References
- Subcutaneous bio-absorbable pellets of norethindrone for contraception in women: Phase I Clinical Study.Fertil Steril. 1984; 41: 726
- Radioimmunoassay of plasma norethindrone after ethynodiol diacetate administration.J Steroid Biochem. 1977; 8: 167
- Horrocks D.L. Organic Scintillators and Liquid Scintillation Counting. Academic Press, New York1977: 747
- Plasma levels of levonorgestrel in women during long-term use of Norplant.Contraception. 1981; 23: 197
- Clinical assessment of subdermal implant of megestrol acetate, d-norgestrel and norethindrone as a long-term contraception in women.Contraception. 1975; 12: 615
Article info
Publication history
Accepted:
August 30,
1984
Received:
July 2,
1984
Identification
Copyright
© 1984 Published by Elsevier Inc.
