US Cycle Control and Blood Pressure Study | NCT00920985

Official Title

Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 µg Ethinylestradiol and 100 µg Levonorgestrel in a 21-day Regimen for 7 Cycles in 400 Women

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Gestodene/EE (FC Patch Low, BAY86-5016)
Arm 2	Active Comparator		Drug: Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gestodene/EE (FC Patch Low, BAY86-5016)	Drug	21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2

Outcomes Module

Measure	Description	Time Frame
Cycle control parameters and bleeding pattern indices		Treatment cycles 2-7

Secondary Outcomes

Measure	Description	Time Frame
Number of pregnancies while on treatment up to 14 days after removal of the last patch		7 treatment cycles each consisting of 28 days and follow-up period of 14 days
Evaluation of blood pressure changes during the dosing-free interval		7 treatment cycles each consisting of 28 days

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Chandler	Arizona	85225-2909	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25453585	Derived	Merz M, Kroll R, Lynen R, Bangerter K. Bleeding pattern and cycle control of a low-dose transdermal contraceptive patch compared with a combined oral contraceptive: a randomized study. Contraception. 2015 Feb;91(2):113-20. doi: 10.1016/j.contraception.2014.10.004. Epub 2014 Oct 13.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

ID	Term
D003276	Contraceptives, Oral
D019304	Ethinyl Estradiol-Norgestrel Combination

Ancestor Terms

ID	Term
D003271	Contraceptive Agents, Female
D003270	Contraceptive Agents
D012102	Reproductive Control Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D045506	Therapeutic Uses
D004997	Ethinyl Estradiol
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D009644	Norgestrel
D009652	Norpregnenes
D042782	Estrogenic Steroids, Alkylated
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists