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Effect of Norgestrel 75 mcg Study on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill

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ClinicalTrials.gov Identifier: NCT03585712
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Health Decisions
Information provided by (Responsible Party):
HRA Pharma

Brief Summary:

Norgestrel 75 mcg is a progestin-only pill (POP), which is a kind of oral birth control pill.

To be effective in preventing pregnancy, this kind of birth control pill is supposed to be taken every day at the same time, without delaying the intake for more than 3 hours.

This study aims to find out if taking the pill 6 hours late or not taking it for one day will affect the way it works.


Condition or disease Intervention/treatment Phase
Contraception Drug: Norgestrel 0.075 MG Phase 2

Detailed Description:

This study is an exploratory, prospective, multi-center, randomized, cross-over study to assess the effect of norgestrel 75 mcg on cervical mucus and ovarian activity during reported perfect daily use, after a delayed intake of 6 hours and after a missed pill.

After a screening period up to one month, depending on the menstrual cycle of the subject, the subjects will take norgestrel 75 mcg for three 28-day treatment periods, every day at the same time except for one day in the middle of treatment period 2 and treatment period 3 where they will either take it 6 hours late or not take it.

They will be randomized to 2 sequences, either 6 hours delayed intake in treatment period 2 and missed pill in treatment period 3 or the opposite.

After the end of treatment period 3, a follow-up up to 12 days may be required to follow ovarian activities.

Subjects will have visits twice a week and sometimes more often to assess the effects of the pill on:

  • cervical mucus properties by a cervical mucus sampling
  • ovarian activity by a vaginal ultrasound (TVUS)
  • reproductive hormones levels by a blood sample (Progesterone (P4), Estradiol (E2), Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH))
  • plasma drug level by a blood sample

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Cross-over Study to Assess the Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
Drug Information available for: Norgestrel

Arm Intervention/treatment
Arm A: Delayed then Missed Pill
Treatment period 2, visit 2R: 6 hour delayed intake of Norgestrel 75 mcg Treatment period 3, visit V3R: missed pill of Norgestrel 75 mcg
Drug: Norgestrel 0.075 MG
Subjects will take norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
Other Name: Norgestrel 75 mcg

Arm B: Missed then Delayed Pill
Treatment period 2, visit 2R: missed pill of Norgestrel 75 mcg Treatment period 3, visit V3R: 6 hour delayed intake of the pill of Norgestrel 75 mcg
Drug: Norgestrel 0.075 MG
Subjects will take norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
Other Name: Norgestrel 75 mcg




Primary Outcome Measures :
  1. Cervical mucus score [ Time Frame: From Day 1 to Day 84 (if no follow-up) or up to Day 96 (if follow-up) ]

    Cervical Mucus Score between 0 and 12

    The score is the sum of 4 subscores:

    • viscosity from 0 (thick, highly viscous) to 3 (watery,minimally viscous)
    • ferning from 0 (no crystallization) to 3 (tertiary and quaternary stem ferning)
    • spinnbarkeit from 0 (<1 cm) to 3 (>= 9 cm)
    • rank for cells from 0 (>20 cells per High Power Field or >1000 cells per μL) to 3 (0 cell)


Secondary Outcome Measures :
  1. Ovarian activity score [ Time Frame: From Day 1 to Day 84 (if no follow-up) or up to Day 90 (if follow-up) ]

    Ovarian Activity Score between 1 and 7:

    • 1= No ovarian activity
    • 2= Potential activity
    • 3= Non-active follicle like structure
    • 4= Active follicle like structure
    • 5= Postovulatory, low progesterone level
    • 6= Postovulatory, intermediate progesterone level
    • 7= Postovulatory, high progesterone level



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women in good overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care
  • Women between 18 and 35 years inclusive at the screening visit
  • BMI< 32 kg/m²
  • Regular menstrual cycles between 21 and 35 days when not using hormonal contraception.

    • Subjects postpartum or post-abortal must have one normal menstrual cycle (2 menses) prior to enrollment.
    • Subjects previously using Intra-Uterine Device (IUD) or taking hormonal contraception (or any other hormonal treatment, except an injectable treatment) need to have at least one menstrual cycle (2 menses) without the treatment before screening.
    • Subject previously using an injectable (DMPA), must have had their last injection at least 9 months before screening.
  • Women not at risk of pregnancy: not sexually active, or willing to protect all acts of intercourse with condoms, or have a sterile partner or have undergone previous tubal ligation (including validated Essure), or be in a same sex relationship.
  • Women able to give informed consent form to participate in the study and in the opinion of the investigator able to follow all study requirements, use the study medication and record the requested information appropriately
  • Intact uterus and both ovaries
  • At least one progesterone concentration > 3 ng/mL (>10 nmol/L) during the luteal phase of the screening period

Exclusion Criteria:

  • Pregnant as confirmed by positive high-sensitivity urine pregnancy test at enrollment visit
  • Trying to conceive or desire to conceive in the next 3 months
  • Currently breastfeeding, or within the last 2 months
  • Known Polycystic Ovarian Syndrome (PCOS)
  • Cancer (or past history of any carcinoma or sarcoma)
  • Known abnormal thyroid status, if in clinical judgment of the investigator it cannot be controlled during the study
  • Known hypersensitivity to the ingredients of the test active substances or its excipients
  • Current acute liver disease and/or benign liver tumors
  • Have vaginal or cervical infection including clinical evidence of bacterial vaginosis
  • Evidence of abnormal cervical lesion
  • History of excisional or ablative treatment procedure on cervix (ie. Loop Electrosurgical Excision Procedure (LEEP), Cryotherapy, Cold Knife Cone)
  • Undiagnosed abnormal uterine bleeding
  • Prior malabsorptive-type bariatric surgery
  • Known or suspected alcoholism or illicit drug abuse
  • Use of any hormonal contraception or IUD other than the study medication during the study (including ulipristal acetate for emergency contraception in the past 5 days)
  • Use of any medications that can interfere with the metabolism of progestin-based contraceptives (e.g CYP3A4 enzymes inducers or inhibitors, etc)
  • Unstable diabetes mellitus
  • Current participation in any other trial of an investigational medicine or participation in the past two months (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies, whichever is the longer) before screening
  • Abnormalities in laboratory results or TVUS performed at screening visit recognized as clinically significant by the investigator
  • Conditions not suitable for frequent TVUS examinations, (e.g. virgo intacta)
  • In custody or submitted to an institution due to a judicial order
  • Relative or household member of the investigator's or sponsor's staff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585712


Contacts
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Contact: Agnès Hemon +33140331130 a.hemon@hra-pharma.com

Locations
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United States, California
University of California Davis Recruiting
Sacramento, California, United States, 95616
Contact: Courtney Overstreet    916-734-6846    hs-obgynresearch@ucdavis.edu   
Principal Investigator: Mitchell Creinin, MD         
United States, Oregon
Oregon Health and Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Emily Padua    503-494-3666    paduae@ohsu.edu   
Principal Investigator: Alison Edelman, MD         
Sponsors and Collaborators
HRA Pharma
Health Decisions
Investigators
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Principal Investigator: Alison Edelman, MD Oregon Health and Sciences University
Principal Investigator: Mitchell Creinin, MD University of California, Davis

Additional Information:
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Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT03585712     History of Changes
Other Study ID Numbers: 151042-002
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by HRA Pharma:
Birth Control
Progestin Only Pill
Estrogen Free Pill
Norgestrel
Oral Contraception
Female Contraception
Cervical Mucus
Ovarian Activity

Additional relevant MeSH terms:
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Norgestrel
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs