Ovulatory effects of three oral contraceptive regimens: a randomized, open-label, descriptive trial.
OBJECTIVE
This study describes ovarian activity suppression of a 21/7-active low-dose combined oral contraceptive (COC) regimen that included only ethinyl estradiol (EE) during the traditional hormone-free interval (HFI) and two commercially available 28-day regimens, a 24/4 and a 21/7 regimen.


METHODS
The randomized, open-label, parallel-group descriptive study was conducted at two US sites. Healthy, reproductive-aged women (n=146) were randomized to one of three groups for three consecutive 28-day cycles, as follows: treatment 1 (n=39 completed): 21/7-active COC [21 days of 150 mcg desogestrel (DSG)/20 mcg EE, followed by 7 days of 10 mcg EE (DSG/EE+7 days EE)], treatment 2 (n=39 completed): 24 days of 3mg drospirenone (DRSP)/20 mcg EE, followed by 4 placebo (PBO)-pill days (DRSP/EE+4 days PBO) and treatment 3 (n=42 completed): 21 days of 100 mcg levonorgestrel (LNG)/20 mcg EE, followed by 7 PBO-pill days (LNG/EE+7 days PBO). The primary outcome was ovarian activity suppression assessed by transvaginal ultrasound and serum hormone concentrations and classified using the Hoogland and Skouby (H/S) method.


RESULTS
Ovarian activity rate (H/S grade 4 or 5) was low for all three treatments: 0% [95% confidence interval (CI) 0-2.8] for DSG/EE+7 days EE, 1% (95% CI 0.2-5.2) for DRSP/EE+4days PBO and 1% (95% CI 0-3.9) for LNG/EE+7 days PBO. All three treatments showed similar suppression of serum progesterone, 17β-estradiol, follicle-stimulating hormone and luteinizing hormone levels.


CONCLUSIONS
The 21/7-active low-dose COC regimen (DSG/EE+7 days EE) showed ovarian activity suppression that was similar to the 24/4 (DRSP/EE+4 days PBO) and 21/7 (LNG/EE+7days PBO) regimens.


CONCLUSIONS
The 21/7-active low-dose COC regimen (DSG/EE+7 days EE) that included only EE during the traditional HFI showed suppression of ovarian follicular activity that was similar to the 24/4 (DRSP/EE+4days PBO) and the 21/7 (LNG/EE+7 days PBO) comparator regimens.
Clinical Research of Philadelphia, 9501 Roosevelt Blvd., Suite 404, Philadelphia, PA 19114, USA. Electronic address: seidmanlb@aol.com.
Larry
L
Seidman
Women's Clinical Research Center, 3216 NE 45th Place, Suite 100, Seattle, Washington 98105, USA. Electronic address: rkroll@seattlewomens.com.
Robin
R
Kroll
Teva Global Medical Affairs, 41 Moores Road, Frazer, PA 19355, USA. Electronic address: Brandon.Howard@tevapharm.com.
Brandon
B
Howard
Teva Branded Pharmaceutical Products, R&D, Inc., 41 Moores Road, Frazer, PA, 19355, USA. Electronic address: nancyricciotti@gmail.com.
Nancy
N
Ricciotti
Teva Branded Pharmaceutical Products, R&D, Inc., 1027 Squires Drive, West Chester, PA, 19382, USA. Electronic address: Jennifer.Hsieh@tevapharm.com.
Jennifer
J
Hsieh
Teva Global Medical Affairs, 16 Basel St., room 2011, Petach Tikva 49131, Israel. Electronic address: Herman.Weiss@teva.co.il.
Herman
H
Weiss
D000328:Adult; D000736:Androstenes / Q000494:pharmacology*; D003280:Contraceptives, Oral, Synthetic / Q000494:pharmacology*; D017135:Desogestrel / Q000494:pharmacology*; D004338:Drug Combinations; D004958:Estradiol / Q000097:blood; D004997:Ethinyl Estradiol / Q000494:pharmacology*; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D016912:Levonorgestrel / Q000494:pharmacology*; D007986:Luteinizing Hormone / Q000097:blood; D010053:Ovary / Q000000981:diagnostic imaging; D034445:Ovulation Inhibition / Q000097:blood / Q000187:drug effects*; D011374:Progesterone / Q000097:blood; D014463:Ultrasonography
D000736:Androstenes; D003280:Contraceptives, Oral, Synthetic; D004338:Drug Combinations; C534342:drospirenone and ethinyl estradiol combination; C072593:ethinyl estradiol, levonorgestrel drug combination; D004997:Ethinyl Estradiol; D011374:Progesterone; D004958:Estradiol; D016912:Levonorgestrel; D017135:Desogestrel; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone
Combined oral contraception; Hormonal contraception; Hypothalamic-pituitary-ovarian suppression; Low-dose COC; Modified hormone-free interval; Ovarian activity suppression