Skip to main content
MedPathMedPath Home
Clinical Trials/DRKS00034125
DRKS00034125
Completed
Not Applicable

Inne MINILAB Effectiveness Study for Contraceptive Use

Feral GmbH0 sites300 target enrollmentStarted: May 6, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Feral GmbH
Enrollment
300
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 Years to one (—)
Sex
Female

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Investigators

Sponsor
Feral GmbH

Similar Trials

Recruiting
Phase 2
Pharmacokinetic and Pharmacodynamic study
CTRI/2022/06/043170upin Research Inc
Active, not recruiting
Not Applicable
A feasibility study into the contraceptive effect of estetrol alone or combined with either progesterone or desogestel by daily oral administration to healthy female volunteers for 28 days - Ovulation inhibition of estetrolOnly healthy volunteers will participate in this clinical trial. Intended indication: contraception.
EUCTR2007-005476-14-NLPantarhei Bioscience BV
Active, not recruiting
Phase 1
A pilot study to examine the efficacy of vaginally administered oestradiol in the treatment of faecal incontinence in post menopausal womeFaecal Incontinence
EUCTR2005-001975-37-GBorth West London NHS Trust43
Completed
Not Applicable
Role of diet in controlling HypertensioHealth Condition 1: I10- Essential (primary) hypertension
CTRI/2012/09/002967Mahesh Bhattacharyya Homoeopathic Medical College and Hospital30
Completed
Not Applicable
Is task-related circuit training an effective means of providing rehabilitation to an acute stroke sample? A controlled trial.Stroke patients undergoing inpatient rehabilitationStroke -Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation
ACTRN12605000016639Royal Adelaide Hospital78