## Protocol Section
### Identification Module
**NCT ID:** NCT00933179

**Brief Title:** FC Patch Low: Metabolism Study

**Official Title:** A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period

#### Organization Study ID Info
**ID:** 91557
#### Organization
**Class:** INDUSTRY
**Full Name:** Bayer
#### Secondary ID Infos
**ID:** 2008-007024-26
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2010-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-11-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-11-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-09

**Type:** ACTUAL

#### Start Date
**Date:** 2009-06

**Status Verified Date:** 2014-11

#### Study First Post Date
**Date:** 2009-07-07
**Type:** ESTIMATED
**Study First Submit Date:** 2009-07-03
**Study First Submit QC Date:** 2009-07-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bayer

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.

### Conditions Module

**Conditions:**

- Contraception

**Keywords:**

- Prevention of pregnancy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Gestodene/EE Patch (BAY86-5016)

**Label:** Arm 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)

**Label:** Arm 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 1

**Description:** 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles

**Name:** Gestodene/EE Patch (BAY86-5016)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm 2

**Description:** 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles

**Name:** EE/Levonorgestrel (Microgynon, BAY86-4977)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Prothrombin fragment 1+2, D-dimer

**Time Frame:** Screening, visit 3-7

#### Secondary Outcomes

**Measure:** Procoagulatory parameters

**Time Frame:** Screening, visit 3-7

**Measure:** Anticoagulatory parameters

**Time Frame:** Screening, visit 3-7

**Measure:** Thrombin and Fibrin turnover parameters

**Time Frame:** Screening, visit 3-7

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy woman requesting contraception
* Normal cervical smear not requiring further follow-up
* History of regular cyclic menstrual periods
* Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods

Exclusion Criteria:

* Pregnancy or lactation - Obesity (Body Mass Index \[BMI\] \> 30.0 kg/m2)
* Any diseases or conditions that can compromise the function of the body systems
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Any disease or condition that may worsen under hormonal treatment
* Undiagnosed abnormal genital bleeding
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Berlin

**Country:** Germany

**Zip:** 10115

#### Overall Officials

**Official 1:**

**Affiliation:** Bayer

**Name:** Bayer Study Director

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Junge W, Heger-Mahn D, Trummer D, Merz M. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study. Drugs R D. 2013 Sep;13(3):223-33. doi: 10.1007/s40268-013-0028-2.

**PMID:** 24043457

#### See Also Links

**Label:** Click here to find information about studies related to Bayer Healthcare products conducted in Europe

**URL:** http://www.clinicaltrialsregister.eu/

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003280

- Term: Contraceptives, Oral, Synthetic

- ID: D000003276

- Term: Contraceptives, Oral

- ID: D000003277

- Term: Contraceptives, Oral, Combined

- ID: D000003278

- Term: Contraceptives, Oral, Hormonal

- ID: D000003282

- Term: Contraceptives, Postcoital, Hormonal

- ID: D000003281

- Term: Contraceptives, Postcoital

- ID: D000003283

- Term: Contraceptives, Postcoital, Synthetic

- ID: D000011372

- Term: Progestins

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M8145

- Name: Ethinyl Estradiol

- Relevance: LOW

- As Found: Unknown

- ID: M266284

- Name: Gestodene

- Relevance: HIGH

- As Found: FEES

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M19256

- Name: Levonorgestrel

- Relevance: HIGH

- As Found: SBRT

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21285

- Name: Ethinyl Estradiol-Norgestrel Combination

- Relevance: HIGH

- As Found: Clotting

- ID: M266279

- Name: Estradiol 17 beta-cypionate

- Relevance: LOW

- As Found: Unknown

- ID: M266280

- Name: Estradiol 3-benzoate

- Relevance: LOW

- As Found: Unknown

- ID: M8108

- Name: Estradiol

- Relevance: LOW

- As Found: Unknown

- ID: M234941

- Name: Polyestradiol phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M265601

- Name: Ethinyl estradiol, levonorgestrel drug combination

- Relevance: HIGH

- As Found: Clotting

- ID: M12581

- Name: Norgestrel

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

- ID: M6501

- Name: Contraceptives, Oral, Combined

- Relevance: LOW

- As Found: Unknown

- ID: M6502

- Name: Contraceptives, Oral, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6505

- Name: Contraceptives, Postcoital

- Relevance: LOW

- As Found: Unknown

- ID: M14244

- Name: Progestins

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016912

- Term: Levonorgestrel

- ID: C000072593

- Term: Ethinyl estradiol, levonorgestrel drug combination

- ID: D000019304

- Term: Ethinyl Estradiol-Norgestrel Combination

- ID: C000033273

- Term: Gestodene

### Misc Info Module

- Version Holder: 2024-05-24
