ContraceptionE2NCT05587920
Effect of Oestrogen on Musculoskeletal Outcomes
An observational study of Contraception and Estrogen Deficiency, run by Army Health Branch, British Army at 1 site in United Kingdom.
Trial summary
This cross-sectional comparison and prospective cohort design study will investigate differences in calcium metabolism, biochemical markers of bone and reproductive health, musculoskeletal health, and iron status between women using different hormonal contraceptives (combined oral contraceptive pill (COCP), hormonal… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Estrogen Deficiency, Estrogen Excess
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2021to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women of reproductive age.
Who may be able to join
- Aged 18-40 years old
- No hormonal contraceptive use (with regular menstrual cycles 24-35 days in length, and have not been taking any hormonal contraceptives for at least 12 months), or;
- Use of the combined oral contraceptive pill containing ≥25 mg ethinyl-oestradiol (EE) and an anti/low androgenic progestin for at least 12 months, or;
- Use of the hormonal coil (IUS) continuously for at least 2 years, or;
- Use of the hormonal implant continuously for at least 2 years, or;
- Use of the hormonalDMPA injection continuously for at least 2 years;
- Weight stable (no change in self-reported body mass ≥ 5% over the previous 3 months);
- BMI between 18 and 30 kg·m2.
Who cannot join
- Taking a hormonal contraceptive other than the combined oral contraceptive pill containing ≥25 mg EE and an anti/low androgenic progestin, hormonal coil (IUS), the hormonal contraceptive implant or the DMPA hormonal injection;
- History of DMPA hormonal injection use in those women not currently using the DMPA hormonal injection;
- Diagnosed Premature Ovarian Insufficiency;
- Pregnancy;
- Less than 2 years postpartum;
- Given birth to more than 2 children;
Show all 24Show fewer
- Evidence of disordered eating (≥ 20 on the EAT-26);
- Any self-diagnosed eating disorder;
- Self-reported change in body mass of ≥ 5% over the previous 3 months;
- Body mass index of < 18 or > 30 kg·m2;
- Evidence of menstrual disturbance (oligomenorrhea: < 9 menstrual cycles in previous 12 months or amenorrhoea: ≤ 3 menstrual cycles in the previous 12 months);
- Habitual smoking (regularly smoking more than 10 cigarettes per day);
- Taking any medications known to affect bone or calcium metabolism (e.g., treatment for thyroid disorders).
- Total 25-hydroxyvitamin D (25(OH)D)level < 30 nmol/l at baseline, confirmed with a venous blood sample;
- Self-declared history of heart, liver or kidney disease, diabetes, or thyroid disorder;
- Self-reported bone fracture in the previous 12 months.
- Local oedema;
- Local skin infection or cellulitis;
- Prior clinical or stress fracture in the tibial diaphysis;
- Dermatological lesions around the measurement site;
- Focal tibial lesions like in primary or metastatic tumour, Paget's disease, Gaucher;
- Osteomyelitis of the tibia;
- Systemic infection or fever (unless unrelated to infection);
- Allergy to lidocaine.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Army Health and Performance Laboratory
Camberley, Surrey, GU15 4PQ
Thomas J O'Leary, PhD, 03001638204, thomas.oleary100@mod.gov.uk
Charlotte V Coombs, PhD, 03001548583, charlotte.coombs.102@mod.gov.uk
About this study
Official title: The Effect of Menstrual Cycle Phase and Hormonal Contraceptives on Bone Metabolism, Reproductive Status, Iron Status and Musculoskeletal Health
This cross-sectional comparison and prospective cohort design study will investigate differences in calcium metabolism, biochemical markers of bone and reproductive health, musculoskeletal health, and iron status between women using different hormonal contraceptives (combined oral contraceptive pill (COCP), hormonal implant, hormonal intra-uterine system (IUS), hormonal contraceptive injection, and eumenorrheic non-hormonal contraceptive users). The same outcomes will also be examined across a menstrual cycle in the eumenorrheic non-hormonal contraceptive users.
The study will test the following hypotheses:
Read more
Hormonal contraceptive use
- Biochemical markers of bone resorption and formation and ratio of urinary 44Ca:42Ca will be higher in the implant and injection groups compared with IUS (which exerts localised effects) and non-HC users (ovulatory phase), and lower in COCP compared with non-HC users;
- Oestradiol and progesterone will be lower in hormonal contraceptive users compared with non-HC users during the ovulatory phase;
- Bone macro- and microstructure, muscle strength, and tissue properties are different in hormonal contraceptive users compared with non-HC users;
- Calcium and bone metabolism, reproductive hormones and musculoskeletal function are different between the pill phase and non-pill phase of COCP use.
Menstrual cycle phase
- Calcium and bone metabolism are lower during the ovulatory phase compared with menses, mid follicular and mid luteal phases.
- Muscle strength and tissue properties are different across the menstrual cycle in non-HC users.
Read the detailed description
Women of reproductive age experience cyclical variation during the menstrual cycle in the female sex steroid hormones, oestrogens and progesterone. Oestrogens performs a primary function in sexual development and reproduction; but, non-reproductive effects on bone, muscle, sinew tissue (e.g. ligaments and tendons) and metabolism may influence injury risk and physical performance. Hormonal contraceptive use, which is common in athletes and military service women, disrupts the reproductive axis and suppresses endogenous hormone production. The purpose of this study is to compare calcium metabolism, biochemical markers of bone and reproductive health, iron status and musculoskeletal health between women using one of four methods of hormonal contraceptives-combined oral contraceptive pill (COCP), hormonal implant, hormonal intra-uterine system (IUS) and hormonal contraceptive injection-and eumenorrheic, non-hormonal contraceptive users (non-HC).
The study will involve a pre-screening visit followed by the main study visits. During the pre-screen visit a venous blood sample will be taken to assess vitamin D status alongside several questionnaires to evaluate health and lifestyle and determine eligibility. Eumenorrheic women will be given a commercially available fertility tracking wearable bracelet (Ava Science Inc.) which will be worn throughout at least two menstrual cycles in the non-HC group for prediction and detection of ovulation. Following pre-screen, the non-HC group will attend the laboratory on four occasions corresponding to the start of the menstrual bleed, the mid-follicular phase, ovulatory phase and mid-luteal phase; the COCP users will attend on two occasions corresponding to the end of the pill phase and the end of the pill-free phase; and the Long Acting Reversible Contraceptives (LARC) users (hormonal injection, hormonal implant, IUS) will attend for a single study visit. On each study visit, participants will provide a urine and venous blood sample, undertake muscle function tests (isokinetic dynamometry and single-leg drop) and have tendon, muscle and ligament characteristic measurements taken (digital palpation). Bone measurements (DXA, HRpQCT, ultrasound) will be taken on one occasion, (day 14 for the non-HC group; day 21 for the COCP group (i.e. end of pill-using weeks); and the single testing day for other LARC groups. The final measurement of impact microindentation (IMI) will be performed using the Osteoprobe within 4 weeks after the skeletal imaging; the IMI is a specialised procedure and will be scheduled in set sessions each month.
Primary Outcomes: Bone calcium balance (44Ca:42Ca) measured in urine.
Secondary Outcomes: Markers of bone turnover, reproductive function, iron status and musculoskeletal health.
- Conditions
- Contraception, Estrogen Deficiency, Estrogen Excess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-hormonal contraceptive users | Women not using any form of hormonal contraceptive. | |
| Combined oral contraceptive pill users | Women using the oral combined oral contraceptive pill. | |
| Hormonal IUS | Women using the hormonal intrauterine system contraceptive. | |
| Hormonal implant | Women using the hormonal contraceptive implant contraceptive. | |
| Hormonal injection | Women using the hormonal injection contraceptive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium balance.
The ratio of the calcium isotopes 44Ca:42Ca in first morning void urine.
Measured: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Secondary outcomes (10)
Circulating concentrations of reproductive hormones at rest following an overnight fast.
Fasted circulating concentration of luteinising hormone, follicle stimulating hormone, oestradiol, progesterone, testosterone, sex-hormone binding globulin.
Measured: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Circulating concentrations of metabolic hormones at rest following an overnight fast.
Fasted circulating concentration of cortisol, cortisol binding globulin, insulin-like growth factor-1 (IGF-1), IGF binding protein 1, IGF binding protein 3, prolactin, relaxin, dehydroepiandrosterone sulfate, thyroid stimulating hormone, free thyroxine, free triiodothyronine.
Measured: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Circulating concentrations of bone turnover markers at rest following an overnight fast.
Fasted circulating concentration of procollagen type 1 N-terminal propeptide (P1NP), bone specific alkaline phosphatase (bone ALP), beta carboxy-terminal cross-linking telopeptide of type 1 collagen (βCTX), intact parathyroid hormone, osteoprotegerin, receptor activator of nuclear factor kappa B ligand (RANKL), ionised and albumin-adjusted calcium, and phosphate.
Measured: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Circulating concentrations of markers of resting iron status following an overnight fast.
Fasted circulating concentration of hepcidin-25, ferritin, soluble transferrin receptor, haemoglobin, and haematocrit.
Measured: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Areal bone mineral density.
Whole-body, lumbar spine, and neck of femur bone mineral density measured by dual-energy x-ray absorptiometry (DXA) scan.
Measured: Single measurement at baseline for long acting reversible contraceptive users, day 21 for combined oral contraceptive users and at ovulation for non-users.
Volumetric bone mineral density at the tibia and radius.
Tibial (4% and 30% site) and radial volumetric bone mineral density measured by high-resolution peripheral quantitative computed tomography.
Measured: Single measurement at baseline for long acting reversible contraceptive users, day 21 for combined oral contraceptive users and at ovulation for non-users
Microarchitecture and structure at the tibia and radius.
Tibial (4% and 30% site) and radial microarchitecture, and geometry measured by high-resolution peripheral quantitative computed tomography.
Measured: Single measurement at baseline for long acting reversible contraceptive users, day 21 for combined oral contraceptive users and at ovulation for non-users
Tibial bone material properties and strength
Tibial bone strength measured by reference point indentation.
Measured: Single measurement for all groups taken no more than one month after completion of the study period.
Muscle function.
Isometric single-leg testing consisting of three maximal isometric contractions at 90° of knee flexion. Dynamic single-leg testing consisting of six repetitions at 60°/s, followed by 15 repetitions at 180°/s. Single-leg drop on each leg from a raised platform.
Measured: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Muscle and tendon properties.
Digital palpation measurement of tone (Hz), stiffness (N/m) and elasticity of the rectus femoris, gastrocnemius, soleus, patella tendon and Achilles tendon using the Myoton device.
Measured: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Army Health Branch, British Army
- Sponsor type
- Other government
- Collaborators
- University of East Anglia, Norwich, United Kingdom, Osteolabs, Kiel, Germany, University of Salford, University of Southampton
- Responsible party
- Principal investigator, Dr. Thomas O'Leary, Army Health Branch, British Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587920
- Sponsor's protocol ID
- 1042/MODREC/20
- Acronym
- E2
- Status last verified
- Apr 2023
- First submitted
- 2 Sep 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared pending approval from the UK Ministry of Defence.
Publications
Myers SJ, Knight RL, Wardle SL, Waldock KA, O'Leary TJ, Jones RK, Muckelt PE, Eisenhauer A, Tang JC, Fraser WD, Greeves JP. Effect of Menstrual Cycle and Hormonal Contraception on Musculoskeletal Health and Performance: Protocol for a Prospective Cohort Design and Cross-Sectional Comparison. JMIR Res Protoc. 2024 Jul 11;13:e50542. doi: 10.2196/50542.
PubMed 38990638
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menstrual Cycle Phase and Hormonal Contraceptives on Bone Metabolism, Reproductive Status, Iron Status and Musculoskeletal Health
- ClinicalTrials.gov ID
- NCT05587920
- Acronym / sponsor ID
- E2 / 1042/MODREC/20
- Conditions
- Contraception, Estrogen Deficiency, Estrogen Excess
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Army Health Branch, British ArmyOther government
- Collaborators
- University of East Anglia, Norwich, United Kingdom, Osteolabs, Kiel, Germany, University of Salford, University of Southampton
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cross-sectional comparison and prospective cohort design study will investigate differences in calcium metabolism, biochemical markers of bone and reproductive health, musculoskeletal health, and iron status between women using different hormonal contraceptives (combined oral contraceptive pill (COCP), hormonal implant, hormonal intra-uterine system (IUS), hormonal contraceptive injection, and eumenorrheic non-hormonal contraceptive users). The same outcomes will also be examined across a menstrual cycle in the eumenorrheic non-hormonal contraceptive users.
The study will test the following hypotheses:
Hormonal contraceptive use
- Biochemical markers of bone resorption and formation and ratio of urinary 44Ca:42Ca will be higher in the implant and injection groups compared with IUS (which exerts localised effects) and non-HC users (ovulatory phase), and lower in COCP compared with non-HC users;
- Oestradiol and progesterone will be lower in hormonal contraceptive users compared with non-HC users during the ovulatory phase;
- Bone macro- and microstructure, muscle strength, and tissue properties are different in hormonal contraceptive users compared with non-HC users;
- Calcium and bone metabolism, reproductive hormones and musculoskeletal function are different between the pill phase and non-pill phase of COCP use.
Menstrual cycle phase
- Calcium and bone metabolism are lower during the ovulatory phase compared with menses, mid follicular and mid luteal phases.
- Muscle strength and tissue properties are different across the menstrual cycle in non-HC users.
Detailed description
Women of reproductive age experience cyclical variation during the menstrual cycle in the female sex steroid hormones, oestrogens and progesterone. Oestrogens performs a primary function in sexual development and reproduction; but, non-reproductive effects on bone, muscle, sinew tissue (e.g. ligaments and tendons) and metabolism may influence injury risk and physical performance. Hormonal contraceptive use, which is common in athletes and military service women, disrupts the reproductive axis and suppresses endogenous hormone production. The purpose of this study is to compare calcium metabolism, biochemical markers of bone and reproductive health, iron status and musculoskeletal health between women using one of four methods of hormonal contraceptives-combined oral contraceptive pill (COCP), hormonal implant, hormonal intra-uterine system (IUS) and hormonal contraceptive injection-and eumenorrheic, non-hormonal contraceptive users (non-HC).
The study will involve a pre-screening visit followed by the main study visits. During the pre-screen visit a venous blood sample will be taken to assess vitamin D status alongside several questionnaires to evaluate health and lifestyle and determine eligibility. Eumenorrheic women will be given a commercially available fertility tracking wearable bracelet (Ava Science Inc.) which will be worn throughout at least two menstrual cycles in the non-HC group for prediction and detection of ovulation. Following pre-screen, the non-HC group will attend the laboratory on four occasions corresponding to the start of the menstrual bleed, the mid-follicular phase, ovulatory phase and mid-luteal phase; the COCP users will attend on two occasions corresponding to the end of the pill phase and the end of the pill-free phase; and the Long Acting Reversible Contraceptives (LARC) users (hormonal injection, hormonal implant, IUS) will attend for a single study visit. On each study visit, participants will provide a urine and venous blood sample, undertake muscle function tests (isokinetic dynamometry and single-leg drop) and have tendon, muscle and ligament characteristic measurements taken (digital palpation). Bone measurements (DXA, HRpQCT, ultrasound) will be taken on one occasion, (day 14 for the non-HC group; day 21 for the COCP group (i.e. end of pill-using weeks); and the single testing day for other LARC groups. The final measurement of impact microindentation (IMI) will be performed using the Osteoprobe within 4 weeks after the skeletal imaging; the IMI is a specialised procedure and will be scheduled in set sessions each month.
Primary Outcomes: Bone calcium balance (44Ca:42Ca) measured in urine.
Secondary Outcomes: Markers of bone turnover, reproductive function, iron status and musculoskeletal health.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non-hormonal contraceptive users | – | –Women not using any form of hormonal contraceptive. |
| Combined oral contraceptive pill users | – | –Women using the oral combined oral contraceptive pill. |
| Hormonal IUS | – | –Women using the hormonal intrauterine system contraceptive. |
| Hormonal implant | – | –Women using the hormonal contraceptive implant contraceptive. |
| Hormonal injection | – | –Women using the hormonal injection contraceptive. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women of reproductive age.
Key inclusion criteria (8 listed)
- Aged 18-40 years old
- No hormonal contraceptive use (with regular menstrual cycles 24-35 days in length, and have not been taking any hormonal contraceptives for at least 12 months), or;
- Use of the combined oral contraceptive pill containing ≥25 mg ethinyl-oestradiol (EE) and an anti/low androgenic progestin for at least 12 months, or;
- Use of the hormonal coil (IUS) continuously for at least 2 years, or;
- Use of the hormonal implant continuously for at least 2 years, or;
Key exclusion criteria (24 listed)
- Taking a hormonal contraceptive other than the combined oral contraceptive pill containing ≥25 mg EE and an anti/low androgenic progestin, hormonal coil (IUS), the hormonal contraceptive implant or the DMPA hormonal injection;
- History of DMPA hormonal injection use in those women not currently using the DMPA hormonal injection;
- Diagnosed Premature Ovarian Insufficiency;
- Pregnancy;
- Less than 2 years postpartum;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calcium balance.
Time frame: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
The ratio of the calcium isotopes 44Ca:42Ca in first morning void urine.
10 secondary outcomes
Circulating concentrations of reproductive hormones at rest following an overnight fast.
Time frame: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Circulating concentrations of metabolic hormones at rest following an overnight fast.
Time frame: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Circulating concentrations of bone turnover markers at rest following an overnight fast.
Time frame: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Circulating concentrations of markers of resting iron status following an overnight fast.
Time frame: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Areal bone mineral density.
Time frame: Single measurement at baseline for long acting reversible contraceptive users, day 21 for combined oral contraceptive users and at ovulation for non-users.
Volumetric bone mineral density at the tibia and radius.
Time frame: Single measurement at baseline for long acting reversible contraceptive users, day 21 for combined oral contraceptive users and at ovulation for non-users
Microarchitecture and structure at the tibia and radius.
Time frame: Single measurement at baseline for long acting reversible contraceptive users, day 21 for combined oral contraceptive users and at ovulation for non-users
Tibial bone material properties and strength
Time frame: Single measurement for all groups taken no more than one month after completion of the study period.
Muscle function.
Time frame: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Muscle and tendon properties.
Time frame: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 38990638Myers SJ, Knight RL, Wardle SL, Waldock KA, O'Leary TJ, Jones RK, Muckelt PE, Eisenhauer A, Tang JC, Fraser WD, Greeves JP. Effect of Menstrual Cycle and Hormonal Contraception on Musculoskeletal Health and Performance: Protocol for a Prospective Cohort Design and Cross-Sectional Comparison. JMIR Res Protoc. 2024 Jul 11;13:e50542. doi: 10.2196/50542.
- Individual participant dataSharing planned: Undecided. Data will be shared pending approval from the UK Ministry of Defence.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Estrogen Deficiency, run by Army Health Branch, British Army at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie P Greeves, PhD (03001597149, julie.greeves143@mod.gov.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium balance. (time frame: Baseline measurement for long acting reversible contraceptive users. Day 21 and 28 of the pill cycle for the combined oral contraceptive pill users. Menses (day 0), mid-follicular, ovulation, and mid-luteal phase for non-users.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05587920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.