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A clinical overview of a new triphasic contraceptive containing gestodene.
Int J Fertil. 1989 Sep; 34 Suppl:40-9.IJ

Abstract

In three ongoing open studies conducted by 50 investigators in Europe, South America, and New Zealand, 639 subjects followed a new triphasic regimen of gestodene (GTD) and ethinyl estradiol (EE) for 3,020 cycles. One study used GTD + EE only, but in each of the other two studies a comparator oral contraceptive (OC) also was given: norethisterone (NET) + EE in one and desogestrel (DSG) + EE in the other. The objective of all three studies was to assess the efficacy, cycle control, and safety of the triphasic GTD + EE. The following is a report of the interim results. Statistical analysis was performed only on differences between groups in the incidences of bleeding irregularities. During six treatment cycles, subjects either followed the GTD + EE regimen (50 micrograms GTD + 30 micrograms EE for 6 days, 70 micrograms GTD + 40 micrograms EE for 5 days, and 100 micrograms GTD + 30 micrograms EE for 10 days) or took triphasic NET + EE or monophasic DSG + EE. Each cycle concluded with a seven-day hiatus in study medication. No pregnancies occurred with any of the contraceptive preparations (Pearl Index = 0). Compliance was good in all studies and a majority of subjects were still participants at cycle 6. Normal bleeding was reported during 92% of the total evaluable cycles of GTD + EE use. Cycle control with GTD + EE was superior to that with NET + EE or DSG + EE: Breakthrough bleeding occurred in 1.5% of the pooled GTD + EE cycles versus 6.6% of the NET + EE cycles and 2.6% of the DSG + EE cycles; spotting occurred in 4.5% of the GTD + EE cycles versus 9.7% of the NET + EE cycles and 10.3% of the DSG + EE cycles; and breakthrough bleeding plus spotting occurred in 2.1% of the GTD + EE cycles versus 8.1% of the NET + EE cycles and 4.6% of the DSG + EE cycles. Amenorrhea occurred in 2.0% of the cycles with NET + EE, but was reported by only 0.3% of all the subjects given GTD + EE and 0.7% of those given DSG + EE. Cycle length and intensity of bleeding changed little during the use of any of the study preparations. Mean length of withdrawal bleeding during the GTD + EE regimen shortened from 4.5 days (prestudy) to 4.0 days. With each OC, the subjects' mean weight during cycles 3 and 6 differed less than 0.5 kg from baseline values.(

ABSTRACT

TRUNCATED AT 400 WORDS)

Authors+Show Affiliations

Wyeth-Ayerst International Inc., Philadelphia, Pennsylvania.

Pub Type(s)

Clinical Trial
Controlled Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

2576257

Citation

Christie, T. "A Clinical Overview of a New Triphasic Contraceptive Containing Gestodene." International Journal of Fertility, vol. 34 Suppl, 1989, pp. 40-9.
Christie T. A clinical overview of a new triphasic contraceptive containing gestodene. Int J Fertil. 1989;34 Suppl:40-9.
Christie, T. (1989). A clinical overview of a new triphasic contraceptive containing gestodene. International Journal of Fertility, 34 Suppl, 40-9.
Christie T. A Clinical Overview of a New Triphasic Contraceptive Containing Gestodene. Int J Fertil. 1989;34 Suppl:40-9. PubMed PMID: 2576257.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A clinical overview of a new triphasic contraceptive containing gestodene. A1 - Christie,T, PY - 1989/9/1/pubmed PY - 1989/9/1/medline PY - 1989/9/1/entrez KW - Bleeding KW - Clinical Research KW - Contraception KW - Contraceptive Agents, Estrogen--administraction and dosage KW - Contraceptive Agents, Female--administraction and dosage KW - Contraceptive Agents, Progestin--administraction and dosage KW - Contraceptive Agents--administraction and dosage KW - Contraceptive Methods--side effects KW - Data Collection KW - Diseases KW - Ethinyl Estradiol--administraction and dosage KW - Family Planning KW - Incidence KW - Measurement KW - Menstrual Cycle KW - Menstruation KW - Norethindrone--administraction and dosage KW - Oral Contraceptives--side effects KW - Reproduction KW - Research Methodology KW - Signs And Symptoms SP - 40 EP - 9 JF - International journal of fertility JO - Int. J. Fertil. VL - 34 Suppl N2 - In three ongoing open studies conducted by 50 investigators in Europe, South America, and New Zealand, 639 subjects followed a new triphasic regimen of gestodene (GTD) and ethinyl estradiol (EE) for 3,020 cycles. One study used GTD + EE only, but in each of the other two studies a comparator oral contraceptive (OC) also was given: norethisterone (NET) + EE in one and desogestrel (DSG) + EE in the other. The objective of all three studies was to assess the efficacy, cycle control, and safety of the triphasic GTD + EE. The following is a report of the interim results. Statistical analysis was performed only on differences between groups in the incidences of bleeding irregularities. During six treatment cycles, subjects either followed the GTD + EE regimen (50 micrograms GTD + 30 micrograms EE for 6 days, 70 micrograms GTD + 40 micrograms EE for 5 days, and 100 micrograms GTD + 30 micrograms EE for 10 days) or took triphasic NET + EE or monophasic DSG + EE. Each cycle concluded with a seven-day hiatus in study medication. No pregnancies occurred with any of the contraceptive preparations (Pearl Index = 0). Compliance was good in all studies and a majority of subjects were still participants at cycle 6. Normal bleeding was reported during 92% of the total evaluable cycles of GTD + EE use. Cycle control with GTD + EE was superior to that with NET + EE or DSG + EE: Breakthrough bleeding occurred in 1.5% of the pooled GTD + EE cycles versus 6.6% of the NET + EE cycles and 2.6% of the DSG + EE cycles; spotting occurred in 4.5% of the GTD + EE cycles versus 9.7% of the NET + EE cycles and 10.3% of the DSG + EE cycles; and breakthrough bleeding plus spotting occurred in 2.1% of the GTD + EE cycles versus 8.1% of the NET + EE cycles and 4.6% of the DSG + EE cycles. Amenorrhea occurred in 2.0% of the cycles with NET + EE, but was reported by only 0.3% of all the subjects given GTD + EE and 0.7% of those given DSG + EE. Cycle length and intensity of bleeding changed little during the use of any of the study preparations. Mean length of withdrawal bleeding during the GTD + EE regimen shortened from 4.5 days (prestudy) to 4.0 days. With each OC, the subjects' mean weight during cycles 3 and 6 differed less than 0.5 kg from baseline values.(ABSTRACT TRUNCATED AT 400 WORDS) SN - 0020-725X UR - https://www.unboundmedicine.com/medline/citation/2576257/A_clinical_overview_of_a_new_triphasic_contraceptive_containing_gestodene_ DB - PRIME DP - Unbound Medicine ER -