A randomised, open-label, multi-centre, dose-finding study to evaluate cycle control of 15 mg or 20 mg estetrol combined with either 150 µg levonorgestrel or 3 mg drospirenone, compared to a combined oral contraceptive containing estradiol valerate and dienogest. - FIESTA study
- Conditions
- Only healthy premenopausal volunteers will participate in this clinical trial. Intended indication: contraception.MedDRA version: 12.1Level: LLTClassification code 10036556Term: Pregnancy
- Registration Number
- EUCTR2010-019865-26-FI
- Lead Sponsor
- Estetra S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1.Women aged 18-35 years (inclusive) at the time of screening who are willing to use a COC for 4 subsequent cycles
2.Good physical and mental health as judged by the investigator determined by medical history, physical examination, clinical laboratory and vital signs
3.Regular menstrual cycle (24-35 days) prior to screening
4.Body mass index between (=) 18 and (=) 30 kg/m2
5.Willing to give informed consent in writing
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation (exclusion criterion only applicable for women who are not using a hormonal contraceptive method at the time of screening)
2.Previous use of progestogen-only contraceptive methods (e.g. minipill, implant or IUD) during the last 3 months or during the last 6 months for depot progestogen preparations or an injectable hormonal method of contraception (e.g. Depo-provera®)
3.Use of phytoestrogens
4.No spontaneous menstruation has occurred following a delivery or abortion
5.Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation
6.Status post-partum or post-abortion within a period of 2 months before screening
7.Pregnancy during accurate hormonal contraceptive use in the past
8.Intention to become pregnant during the study
9.An abnormal cervical smear
10.Untreated Chlamydia infection
11.Known or suspected breast cancer or a history of breast cancer
12.A history of (within 12 months) alcohol or drug abuse
13.Any clinically relevant abnormality following review of medical history, laboratory results and physical/gynaecological examination at screening as judged by the investigator;
14.Contraindications for contraceptive steroids
15.In accordance with the SmPC/Package Insert of DRSP-EE, additional contraindications related to the antimineralocorticoid activity of drospirenone
16.Use of one or more of the following medications:
-Antihypertensive drugs
-Present use or use within 2 months prior to the start of the study medication of the following drugs: phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John’s Wort);
17.Administration of any other investigational drug within 2 months prior to screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: •To assess vaginal bleeding patterns (cycle control) of 15 mg or 20 mg E4 combined with either 150 µg LNG or 3 mg DRSP during a 24:4 treatment regimen;Secondary Objective: • To investigate ovulation inhibition<br>• To investigate the effect on sex hormone-binding globulin (SHBG)<br>• To assess pregnancy rate<br>• To evaluate satisfaction, dysmenorrhoea, acne, and body weight<br>• To investigate return of menstruation after treatment with E4-LNG or E4-DRSP combined oral contraception (COC)<br>• To evaluate general safety and acceptability;Primary end point(s): Primary objective:<br>• To assess vaginal bleeding patterns (cycle control) of 15 or 20 mg E4 combined with either 150 µg LNG or 3 mg DRSP during a 24:4 treatment regimen
- Secondary Outcome Measures
Name Time Method