Effect of levonorgestrel contraceptive implants, NORPLANT®, on blood coagulation

Shaaban, Mamdouh M.; Elwan, Sawsan I.; El-Kabsh, M.Y.; Farghaly, Sohair A.; Thabet, Nabila M.

doi:10.1016/0010-7824(84)90034-9

Cited by 43 publications

(4 citation statements)

References 17 publications

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“…The reports in the literature concerning platelet count showed lack of consensus (Shaaban et al, 1984;Sivin, 1988;Du et al, 1990;Singh et al, 1993), even though the platelet count at 12 months decreased signi cantly compared to preinsertion concentration (Aisien et al, 2000). The values at 24 and 36 months of studies did not show signi cant change over the 12-month data.…”

Section: Discussionmentioning

confidence: 50%

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Evaluation of menstrual and haematological parameters, after 36 months of Norplant^Rcontraception

Aisien

Sagay

Imade

et al. 2002

Journal of Obstetrics and Gynaecology

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This ongoing prospective longitudinal study involved 23 women who had complete records, of 37 healthy non-breastfeeding informed volunteers recruited from our family planning clinic since August 1997 to the Norplant training programme. Packed cell volume (PCV), white blood cell (WBC) concentration (total and differential and platelet concentration were analysed at pretreatment and at 12, 24 and 36 months' followup. Statistical analysis was with paired t-tests. The level of significance was set at 5%. Each acceptor received a menstrual calendar to document all events of bleeding. The mean PCV was 40.5 +/- 2.4% at pretreatment. This rose to a statistically significant (P < 0.001) mean value of 44.9 +/- 4.4% at 36 months. The mean WBC concentration at pretreatment was 5552 +/- 1423 per mm3 which declined statistically (P < 0.001) to a mean value of 4400 +/- 1281 per mm3 at 12 months without any further significant changes at 24 months (P > 0.6; 4143 +/- 1301 per mm3 and at 36 months (P > 0.9; 4070 +/- 875 per mm3). At 24 months of study the mean concentration of neutrophils, lymphocytes, monocytes eosinophils and basophils did not change significantly from their respective mean concentrations at 12 months. These insignificant changes were also manifested at 36 months of study in the lymphocytes (P > 0.2), eosinophils (P > 0.5) and basophils (P > 0.2), even though there was a significant decrease in the neutrophils (P < 0.05) with a corresponding significant increase (P < 0.001) in the monocyte concentration. However, there was still a significant decrease (P < 0.001) in the WBC at 36 months of study compared with the mean preinsertion value, which was manifested mainly in the neutrophil concentration (1403 +/- 517 per mm3 (P < 0.001). The mean value of platelet count (136260 +/- 27664 per mm3) at 24 months showed no significant change compared with the 12 months value (126174 +/- 37977 per mm3). The value at 36 months (125391 +/- 18858 per mm3), however, still showed a significant decline over the pretreatment mean concentration (208043 +/- 27250 per mm3). None of the acceptors had thrombocytopenia at 24 and 36 months. At 2 years and 3 years of studies 60.9% and 47.8% of Norplant users reported irregular bleeding patterns, mainly of reduced episodes. The continuation rate at 36 months was 100%. Women using the Norplant implant are at an advantage, because in spite of the variable aberrations in their menstrual pattern, the packed cell volume increased. The changes ob-served in the white cell and the platelet concentrations did not lead to adverse effects.

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Section: Discussionmentioning

confidence: 50%

“…Any Norplant effect on platelet concentration has shown lack of consensus, varying from no change, to decrease concentration or an increase in value (Shaaban et al, 1984;Sivin, 1988;Du et al, 1990;Singh et al, 1993). Norplant has been in use in our centre for about 15 years and is gaining popularity.…”

Section: Introductionmentioning

confidence: 97%

Evaluation of menstrual and haematological parameters, after 36 months of Norplant^Rcontraception

Aisien

Sagay

Imade

et al. 2002

Journal of Obstetrics and Gynaecology

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“…Ethinyl estradiol (EE) is a common contraceptive similar to levonorgesterol, which is the active ingredient of the reservoir type device, Norplant (Shaaban et al 1984). EE was used because similar to crystal violet it is also soluble in alcohol, which assisted in the drug loading of small tubes.…”

Section: Discussionmentioning

confidence: 99%

Development and characterization of a scalable microperforated device capable of long-term zero order drug release

Rastogi

Luo

et al. 2010

Biomed Microdevices

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A drug delivery system that consists of microperforated polyimide microtubes was developed and characterized. Two groups of polyimide tubes were used. One set consisted of microtubes (I.D. = 125 microm) with 32.9 +/- 1.7 microm size holes. The second set consisted of larger tubes (I.D. = 1000 microm) with 362-542 microm holes. The number of holes was varied between 1 and 3. The small tubes were loaded with crystal violet (CV) and ethinyl estradiol (EE) and the drug release studies were performed in 0.01 M phosphate buffered saline (PBS) (pH 7.1-7.4) at 37.0 +/- 1.0 degrees C for upto 4 weeks. The large tubes were loaded with CV and the drug release was studied in vitro in PBS and also ex vivo in rabbit's vitreous humor. Linear release rates with R(2) > 0.9900 were obtained for all groups with CV and EE. Release rates of 7.8 +/- 2.5, 16.2 +/- 5.5, and 22.5 +/- 6.0 ng/day for CV and 30.1 +/- 5.8 ng/day for EE were obtained for small tubes. For large tubes, a release rate of 10.8 +/- 4.1, 15.8 +/- 4.8 and 22.1 +/- 6.7 microg/day was observed in vitro in PBS and a release rate of 5.8 +/- 1.8 microg/day was observed ex vivo in vitreous humor.

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“…An important advantage of sustained-release, low-dose progestin contraception is their minimal metabolic effects. Studies of progestin implants have not detected changes outside of the normal range in carbohydrate metabolism, [61][62][63][64] liver function, [64][65][66][67][68] thyroid function, [69][70][71][72] adrenal function, 69,71,73,74 coagulation, 67,68,75,76 levels of immunoglobulins, 61,77 or blood chemistries. 61,66 Initial studies suggested a mild, although not clinically significant, decrease in insulin sensitivity in nondiabetic women.…”

Section: Minimal Metabolic Effectmentioning

confidence: 99%

Implant Contraception

Meckstroth¹,

Darney²

2001

Semin Reprod Med

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The experience of 6 million Norplant users has led to several more advanced implants. Implanon is a single-rod implant system containing a low androgenic progestin and requires 1 to 2 minutes for insertion and removal. Like other implants, Implanon prevents pregnancy by changing the character of the cervical mucus and interfering with luteal function. Unlike Norplant, though, Implanon is designed to prevent ovulation for the full duration of use. Implant contraception has several advantages over other types of contraception including high efficacy, minimal required maintenance, absence of estrogen, and rapid return of fertility after discontinuation. Implants can be a good choice for adolescents; women with hypertension, diabetes, anemia, endometriosis, or other medical problems; and women who are breast-feeding. Irregular bleeding is the most common adverse effect of implants and can be treated with several medication regimens. Preinsertion counseling, however, is the most important factor in ensuring satisfaction with implants. Unfortunately, no implant system is currently available in the United States since August 2000, but Implanon is expected to reach the U.S. market within the next 2 years.

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Effect of levonorgestrel contraceptive implants, NORPLANT®, on blood coagulation

Cited by 43 publications

References 17 publications

Evaluation of menstrual and haematological parameters, after 36 months of Norplant^Rcontraception

Evaluation of menstrual and haematological parameters, after 36 months of Norplant^Rcontraception

Development and characterization of a scalable microperforated device capable of long-term zero order drug release

Implant Contraception

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Effect of levonorgestrel contraceptive implants, NORPLANT®, on blood coagulation

Cited by 43 publications

References 17 publications

Evaluation of menstrual and haematological parameters, after 36 months of NorplantRcontraception

Evaluation of menstrual and haematological parameters, after 36 months of NorplantRcontraception

Development and characterization of a scalable microperforated device capable of long-term zero order drug release

Implant Contraception

Contact Info

Product

Resources

About

Evaluation of menstrual and haematological parameters, after 36 months of Norplant^Rcontraception

Evaluation of menstrual and haematological parameters, after 36 months of Norplant^Rcontraception