INDICATIONS AND USAGE
Gianvi (drospirenone and ethinyl estradiol tablets) 3 mg/0.02 mg is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.
Oral contraceptives are highly effective. Table II lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and contraceptive implants and IUDs, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Gianvi (drospirenone and ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Gianvi (drospirenone and ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR: UNITED STATES.
% of Women Experiencing an Unintended Pregnancy Within the First Year of Use
% of Women Continuing Use at One Year
Method (1)
Typical Use (2)
Perfect Use (3)
(4)
Chance
85
85
40
Spermicides
26
6
63
Periodic abstinence
25
Calendar
9
Ovulation method
3
Sympto-thermal
2
Post-ovulation
1
Withdrawal
19
4
CapWith spermicidal cream or jelly.
Parous women
40
26
42
Nulliparous women
20
9
56
Sponge
Parous women
40
20
42
Nulliparous women
20
9
56
Diaphragm
20
6
56
Condom
Female (Reality)
21
5
56
Male
14
3
61
Pill
5
71
progestin only
0.5
combined
0.1
IUD
Progesterone T
2
1.5
81
Copper T 380A
0.8
0.6
78
Lng 20
0.1
0.1
81
Depo Provera
0.3
0.3
70
Norplant and Norplant-2
0.05
0.05
88
Female sterilization
0.5
0.5
100
Male sterilization
0.15
0.1
100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Guest F, Kowal D, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
Oral Contraceptive Clinical Trial
In the primary contraceptive efficacy study of drospirenone and ethinyl estradiol tablets (3 mg DRSP/0.02 mg EE) of up to 1 year duration, 1,027 subjects were enrolled and completed 11,480 28-day cycles of use. The age range was 17 to 36 years. The racial demographic was: 87.8% Caucasian, 4.6% Hispanic, 4.3% Black, 1.2% Asian, and 2.1% other. Women with a BMI greater than 35 were excluded from the trial. The pregnancy rate (Pearl Index) was 1.41 per 100 woman-years of use based on 12 pregnancies that occurred after the onset of treatment and within 14 days after the last dose of drospirenone and ethinyl estradiol tablets in women 35 years of age or younger during cycles in which no other form of contraception was used.
Acne Clinical Trials
In two multicenter, double blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received drospirenone and ethinyl estradiol tablets or placebo for six 28 day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a clear or almost clear rating on the Investigators Static Global Assessment (ISGA) scale on day 15 of cycle 6, as presented in Table III:
TABLE III: EFFICACY RESULTS FOR ACNE TRIALS*
* Evaluated at day 15 of cycle 6, last observation carried forward for the Intent to treat population
Study 1
Study 2
Drospirenone and Ethinyl Estradiol Tablets N=228
Placebo N=230
Drospirenone and Ethinyl Estradiol Tablets N=218
Placebo N=213
ISGA Success Rate
35 (15%)
10 (4%)
46 (21%)
19 (9%)
Inflammatory Lesions
Mean Baseline CountMean Absolute (%) Reduction
3315 (48%)
3311 (32%)
3216 (51%)
3211 (34%)
Non-inflammatory Lesions
Mean Baseline CountMean Absolute (%) Reduction
4718 (39%)
4710 (18%)
4417 (42%)
4411 (26%)
Total lesions
Mean Baseline CountMean Absolute (%) reduction
8033 (42%)
8021 (25%)
7633 (46%)
7622 (31%)