Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age.

Primary objective:

• To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal bleeding patterns (cycle control), in comparison with a combined oral contraceptive containing estradiol valerate and dienogest

Secondary objectives:

• To investigate ovulation inhibition

• To investigate the effect on SHBG

• To assess pregnancy rate

• To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight

• To investigate return of menstruation after treatment

• To evaluate general safety and acceptability

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Estetra
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Dienogest; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Women willing to use a Combined Oral Contraceptive for 6 subsequent cycles

• Good physical and mental health

• Regular menstrual cycle (24-35 days) prior to screening

• Body mass index between (≥) 18 and (≤) 30 kg/m2

Exclusion Criteria:

• Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation (only applicable for women who are not using a hormonal contraceptive method at the time of screening)

• Previous use of progestogen-only contraceptive methods during the last 3 months or during the last 6 months for depot progestogen preparations or an injectable hormonal method of contraception

• Use of phytoestrogens

• No spontaneous menstruation has occurred following a delivery or abortion

• Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation

• Status post-partum or post-abortion within a period of 2 months before screening

• Pregnancy during accurate hormonal contraceptive use in the past

• Intention to become pregnant during the study

• An abnormal cervical smear within one year before study start

• Untreated Chlamydia infection

• Known or suspected breast cancer or a history of breast cancer

• A history of (within 12 months) alcohol or drug abuse

• Any clinically relevant abnormality

• Contraindications for the contraceptive steroids used in the clinical trial

• Use of antihypertensive drugs or use of medications interacting with the contraceptive steroids used in the clinical trial

• Administration of any other investigational drug within 2 months prior to screening