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

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: estetrol, P 1 and placebo tablets; Drug: estetrol, P2 and placebo tablets; Drug: Estradiol valerate, dienogest and placebo tablets

• Registration Number: NCT01221831
• Lead Sponsor: Estetra

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-15
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
estetrol dose 1 / P1	estetrol, P 1 and placebo tablets	-
estetrol dose 1 / P2	estetrol, P2 and placebo tablets	-
estradiol valerate/dienogest pill	Estradiol valerate, dienogest and placebo tablets	-
estetrol dose 2 / P1	estetrol, P 1 and placebo tablets	-
estetrol dose 2 / P2	estetrol, P2 and placebo tablets	-

Primary Outcome Measures

Name	Time	Method
Recording of vaginal bleeding events (diary) as a measure of Cycle control	6 cycles of 28 days

Secondary Outcome Measures

Name	Time	Method
Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition	6 cycles of 28 days
Patient Reported Outcome questionnaire as a measure of Subject satisfaction	6 cycles of 28 days
Contacts patient-investigator to document Return of menstruation	for up to 1 year follow-up	(only in case the patient does not start up a new hormonal contraceptive method or in case of pregnancy wish)
Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability	up to 8 months
Measurement of SHBG in blood samples to assess the effect of treatment on SHBG	6 cycles of 28 days
Reporting of in-treatment pregnancies as a measure of pregnancy rate	6 cycles of 28 days

Trial Locations

Locations (10)

Väestöliitto Oulu; 🇫🇮 Oulu, Finland

Tampereen Lääkärikeskus Oy; 🇫🇮 Tampere, Finland

Väestöliitto Turku; 🇫🇮 Turku, Finland

Laboratorio Simpanen; 🇫🇮 Kuopio, Finland

Terveystalo Kuopio; 🇫🇮 Kuopio, Finland

YTHS Tampere; 🇫🇮 Tampere, Finland

Mehiläinen Helsinki; 🇫🇮 Helsinki, Finland

Väestöliitto Helsinki; 🇫🇮 Helsinki, Finland

YTHS Jyvaskyla; 🇫🇮 Jyvaskyla, Finland

YTHS Kuopio; 🇫🇮 Kuopio, Finland