(Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP)
Revised: December 2003
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Zovia 1/35E-28. Each light pink tablet contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol.
Zovia 1/50E-28. Each pink tablet contains 1 mg of ethynodiol diacetate and 50 mcg of ethinyl estradiol.
Therapeutic class: Oral contraceptive.
Zovia 1/35E and Zovia 1/50E are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Zovia 1/50E, which contain 50 mcg of estrogen, should not be used unless medically indicated.
Published Studies Related to Zovia (Ethynodiol / Estradiol)
Bioavailability and pharmacokinetics of norethisterone in women after oral doses of ethynodiol diacetate. [1979.02]
PIP: Bioavailability and pharmacokinetics of norethisterone (NE) were studied in 12 women, aged 21-37 years, after oral doses of ethynodiol diacetate (EDA). Plasma NE levels, measured by radioimmunoassay, were used to compare the bioavailability of EDA tablets (Ovulen 50; 1 mg EDA plus .05 mg ethinyl estradiol) with that of a standard oral solution of EDA...
Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial. [1991.04]
A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA 1 mg with EE 35 micrograms for one to eight months...
Complexion changes in oral contraceptive users. Results from a phase IV multicenter trial evaluating the safety and efficacy of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms. [1991.04]
An open-label, phase IV, multicenter survey of obstetrician-gynecologists was conducted to evaluate the efficacy and safety of a low-dose monophasic oral contraceptive, ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms. Surveys from 983 community-based physicians reported on 6,382 women...
Serum and placenta levels of ethynylestradiol in presence of ethynodiol diacetate after oral administration. [1982.07]
PIP: The ethinyl estradiol concentration--in the presence of ethynodiol diacetate--in serum following oral administration was measured by a rapid radioimmunoassay method developed by the authors. It was found that the peak level was reached 1 hour after administration, and even after 12 hours, a significant amount of free ethinyl estradiol was present in the serum...
Clinical Trials Related to Zovia (Ethynodiol / Estradiol)
Impact of Oral Contraceptives on GABA and Neurosteroids [Terminated]
Thus, the proposed study has the following Specific Aims and Hypotheses:
1. To determine in menstruating women ages 18-45 whether an OCP containing ethinyl
estradiol (EE) and the progestin ethinydiol diacetate (ED) increases cortical GABA
concentrations as measured using proton magnetic resonance spectroscopy (1H-MRS) above
that of an OCP containing EE and the progestin norethindrone (NOR).
2. To determine the relationship between changes in occipital GABA concentrations with
acute OCP administration and negative affect with chronic OCP administration over two
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