Russia/Ukraine Suppression of Ovarian Activity Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02550977
• Date of registration: 02/09/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Russia/Ukraine Suppression of Ovarian Activity Study
• Scientific title: Multicenter, Open-label, Uncontrolled Study to Investigate Suppression of Ovarian Activity of a Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in 80 Young Female Volunteers Over 3 Treatment Cycles
• Date of first enrolment: September 18, 2015
• Target sample size: 91
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02550977
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Russian Federation, Ukraine

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy female subjects requesting contraception

- Aged 18 to 35 years (inclusive); smokers must not be older than 30 years

- Normal or clinically insignificant cervical smear not requiring further follow-up

- History of regular cyclic menstrual periods

- Willingness to use nonhormonal methods of contraception during the entire study

- Proven ovulation upon completion of the pretreatment cycle

Exclusion Criteria:

- Pregnancy or lactation

- Obesity (body mass index [BMI] > 30.0 kg/m2)

- Significant skin reaction to transdermal preparations or sensitivity to
surgical/medical tape

- Any disease or condition that may worsen under hormonal treatment

- Use of hormonal contraception other than study medication during the study



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

Intervention(s)

Drug: Gestodene/EE Patch (BAY86-5016)

Primary Outcome(s)

Suppression of ovulatory activity proved by progesterone and estradiol concentrations [Time Frame: Treatment day 29 to day 84]

Secondary Outcome(s)

Number of patients with abnormal safety laboratory [Time Frame: Up to 84 days]

Time course of follicle-stimulating hormone [Time Frame: Day 27 of pretreatment cycle to treatment day 83]

Serum concentration, AUC (area under curve) of ethinyl estradiol [Time Frame: Multiple time points up to treatment day 84]

Serum concentration, AUC (area under curve) of Gestodene [Time Frame: Multiple time points up to treatment day 84]

Time course of luteinizing hormone [Time Frame: Day 27 of pretreatment cycle to treatment day 83]

Number of patients with adverse events [Time Frame: Up to 84 days]

Serum concentration, AUC (area under curve) of Sexual hormone binding globulin [Time Frame: Multiple time points up to treatment day 84]

Secondary ID(s)

16119

Source(s) of Monetary Support

Please refer to primary and secondary sponsors