Biomaterial Database

Bleeding patterns with monophasic and triphasic low-dose ethinyl estradiol combined oral contraceptives. 2008

R Moss Hampton, and Huabin F Zhang, and Christopher Barnowski, and George J Wan

Texas Tech University School of Medicine, Odessa, TX 79763, USA. moss.hampton@ttuhsc.edu

BACKGROUND This retrospective analysis evaluated the association of age and weight with cycle control in women using either of two formulations of low-estrogen-dose oral contraceptives. METHODS Data for this secondary analysis were derived from a randomized multicenter trial assessing the efficacy and safety of norgestimate (NGM) 180/215/250 mcg/ethinyl estradiol (EE) 25 mcg (n=1506) and norethindrone acetate 1 mg/EE 20 mcg (n=1057). In this retrospective analysis, the incidence of breakthrough bleeding/spotting (BTB/S) was evaluated in women stratified by age (18-24, 25-34 and >34 years) and weight (<or=123, 124-155 and >155 lb). RESULTS A lower percentage of women experienced BTB/S with NGM/EE during most cycles, regardless of age or weight, compared with norethindrone acetate/EE. At Cycle 6, the incidences of BTB/S for NGM/EE versus norethindrone acetate/EE were as follows: 18-24 years, 10.9% versus 29.7% (p<.0001); 25-34 years, 10.9% versus 18.6% (p<.001); >34 years, 8.1% versus 19.1% (p<.005); <or=123 lb, 11.0% versus 25.4% (p<.0001); 124-155 lb, 10.0% versus 22.5% (p<.0001); and >155 lb, 10.0% versus 18.3% (p<.01). CONCLUSIONS NGM/EE provided better cycle control as defined by BTB/S compared with norethindrone acetate/EE, regardless of subject age or weight for six cycles.

UI	MeSH Term	Description	Entries
D008598	Menstruation	The periodic shedding of the ENDOMETRIUM and associated menstrual bleeding in the MENSTRUAL CYCLE of humans and primates. Menstruation is due to the decline in circulating PROGESTERONE, and occurs at the late LUTEAL PHASE when LUTEOLYSIS of the CORPUS LUTEUM takes place.
D008796	Metrorrhagia	Abnormal uterine bleeding that is not related to MENSTRUATION, usually in females without regular MENSTRUAL CYCLE. The irregular and unpredictable bleeding usually comes from a dysfunctional ENDOMETRIUM.	Bleeding Between Periods,Breakthrough Bleeding,Dysfunctional Uterine Bleeding,Intermenstrual Bleeding,Spotting,Bleeding, Breakthrough,Dysfunctional Uterine Bleedings,Uterine Bleeding, Dysfunctional
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009640	Norethindrone	A synthetic progestational hormone with actions similar to those of PROGESTERONE but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for CONTRACEPTION.	19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-, (17alpha)-,Ethinylnortestosterone,Norethisterone,Norpregneninolone,Conceplan,Micronor,Monogest,Nor-QD,Norcolut,Norcolute,Norethindrone, (1 beta)-Isomer,Norlutin,Nor QD,NorQD
D009644	Norgestrel	A synthetic progestational agent with actions similar to those of PROGESTERONE. This racemic or (+-)-form has about half the potency of the levo form (LEVONORGESTREL). Norgestrel is used as a contraceptive, ovulation inhibitor, and for the control of menstrual disorders and endometriosis.	18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(+-)-,DL-Norgestrel,Neogest,Ovrette,Postinor,Wy-3707,DL Norgestrel,Wy 3707,Wy3707
D001835	Body Weight	The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.	Body Weights,Weight, Body,Weights, Body
D003277	Contraceptives, Oral, Combined	Fixed drug combinations administered orally for contraceptive purposes.	Combined Oral Contraceptive,Contraceptive Agents, Female, Combined,Oral Contraceptives, Combined,Combined Oral Contraceptives,Contraceptive, Combined Oral,Contraceptives, Combined Oral,Oral Contraceptive, Combined
D003280	Contraceptives, Oral, Synthetic	Oral contraceptives which owe their effectiveness to synthetic preparations.
D004967	Estrogens	Compounds that interact with ESTROGEN RECEPTORS in target tissues to bring about the effects similar to those of ESTRADIOL. Estrogens stimulate the female reproductive organs, and the development of secondary female SEX CHARACTERISTICS. Estrogenic chemicals include natural, synthetic, steroidal, or non-steroidal compounds.	Estrogen,Estrogen Effect,Estrogen Effects,Estrogen Receptor Agonists,Estrogenic Agents,Estrogenic Compounds,Estrogenic Effect,Estrogenic Effects,Agents, Estrogenic,Agonists, Estrogen Receptor,Compounds, Estrogenic,Effects, Estrogen,Effects, Estrogenic,Receptor Agonists, Estrogen
D004997	Ethinyl Estradiol	A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.	19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17alpha)-,Ethynyl Estradiol,Estinyl,Ethinyl Estradiol Hemihydrate,Ethinyl Estradiol, (8 alpha)-Isomer,Ethinyl Estradiol, (8 alpha,17 alpha)-Isomer,Ethinyl Estradiol, (8 alpha,9 beta,13 alpha,14 beta)-Isomer,Ethinyl Estradiol, (9 beta,17 alpha)-Isomer,Ethinyl-Oestradiol Effik,Ethinylestradiol Jenapharm,Ethinyloestradiol,Lynoral,Microfollin,Microfollin Forte,Progynon C,Estradiol, Ethinyl,Estradiol, Ethynyl,Ethinyl Oestradiol Effik,Hemihydrate, Ethinyl Estradiol,Jenapharm, Ethinylestradiol