Inne MINILAB Effectiveness Study for Contraceptive Use
- Conditions
- Contraception
- Registration Number
- DRKS00034125
- Lead Sponsor
- Feral GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 300
I1) Healthy menstruating women, with previous average menstrual cycle lengths of 22 to 35 days inclusive during the past three cycles,
I2) Living in Germany
I3) Over 18 years old
I4) Women using an iPhone 5S or newer, with a Wireless Fidelity (Wi-Fi) connection of at least 2.4 GhZ.
I5) Women agreeing to have regular heterosexual intercourse during the duration of the study (at least once per cycle).
I6) Women agree to not use any form of contraception during their infertile days, and must use one of the following contraceptive methods during their fertile window: abstinence, condom, or diaphragm.
I7) Women accept that there is a risk of unintended pregnancy associated with this study and are in this case intending to carry the pregnancy to term.
E1) Women currently undergoing or having recently undergone hormonal treatment such as hormonal contraception (including oral, progesterone-only and combined hormonal methods, or any other hormonal contraceptive program), fertility treatments, or hormone replacement therapy. Since stopping the treatment, the subject has not yet had 3 regular menstrual cycles. An exception to this is hormonal emergency contraception (morning after-pill).
E2) Women currently using intrauterine copper devices. Since stopping the treatment, the subject has not yet had 1 regular menstrual cycle.
E3) Women currently undergoing or having recently undergone a treatment which may affect her menstrual cycle (this would be mentioned in the patient information leaflet of the treatment, e.g. certain antipsychotics like risperidone, or chemotherapeutic drugs like methotrexate).
E4) Women currently pregnant or who have recently been pregnant (until after the third consecutive period, even if the pregnancy was not carried to term).
E5) Women with known polycystic ovary syndrome or known endometriosis.
E6) Women currently breastfeeding. Women who stopped breastfeeding but did not yet have 3 regular menstrual cycles.
E7) This study is testing the inne MINILAB as a form of contraception. Like all contraception, there is a risk of pregnancy. Women who are not OK with any risk of pregnancy.
E8) Women who have had or have menopausal symptoms such as hot flashes or night sweats.
E9) Women with diagnosed infertility or with an infertile partner, including history of surgical sterilization.
E10) Participation in another clinical trial.
E11) Subject in custody by order of an authority or a court of law.
E12) Subject is a dependent person, e.g. a relative, family member, or member of the Investigator’s or Sponsor’s staff.
E13) Women with current wishes for pregnancy.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Typical-use effectiveness and Perfect-use effectiveness. Where effectiveness is calculated as: 100 - Pearl Index; and Pearl Index is calculated as:<br>[(number of pregnancies * 13)/(total number of cycles)]*100.<br>For Typical-use effectiveness, the number of unintended pregnancies = All pregnancies (including those that might occur during use of other concomitant contraceptives); while for Perfect-use effectiveness calculation, the number of unintended pregnancies = All pregnancies that resulted from correct and consistent use of the method, with date of conception that fall in a low chance of pregnancy” phase, defined by the inne MINILAB.
- Secondary Outcome Measures
Name Time Method sability improvement: List of difficulties encountered by the women using the inne MINILAB